Reported Nov 13, 2024 · Ongoing

Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer

Baxter Healthcare Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer

Lot codes and dates: 69 of 69 products
Products covered by this recall
# Barcodes Product as published
1 00732094259032115340269178117060553883117060553884117060553885119230003169 UDI/DI 00732094259032, Serial Numbers: 115340269178, 117060553883, 117060553884, 117060553885, 119230003169
2 00732094259070117130559202117130559203117130559204 UDI/DI 00732094259070, Serial Numbers: 117130559202, 117130559203, 117130559204
3 00732094259100116270497046117190567440 UDI/DI 00732094259100, Serial Numbers: 116270497046, 117190567440
4 00732094259148117350583961119060000843122090000529 UDI/DI 00732094259148, Serial Numbers: 117350583961, 119060000843, 122090000529
5 00732094259179116240458434116500543985120480000930 UDI/DI 00732094259179, Serial Numbers: 116240458434, 116500543985, 120480000930
6 00732094259230118160628177 UDI/DI 00732094259230, Serial Numbers: 118160628177
7 00732094259261117470596306 UDI/DI 00732094259261, Serial Numbers: 117470596306
8 00732094259285118100618358116110348774116490541753117430591185117510601740 UDI/DI 00732094259285, Serial Numbers: 118100618358, 116110348774, 116490541753, 117430591185, 117510601740
9 00732094259292116460537153118490000226 UDI/DI 00732094259292, Serial Numbers: 116460537153, 118490000226
10 00732094259308116120365527119410001349119410001350119410001351119410001352119410001353119410001354119410001355119410001356119410001357119410001358119410001359119410001360119410001361119410001362119410001363119410001364119410001365119410001366119410001367119410001368119410001369119410001370 UDI/DI 00732094259308, Serial Numbers: 116120365527, 119410001349, 119410001350, 119410001351, 119410001352, 119410001353, 119410001354, 119410001355, 119410001356, 119410001357, 119410001358, 119410001359, 119410001360, 119410001361, 119410001362, 119410001363, 119410001364, 119410001365, 119410001366, 119410001367, 119410001368, 119410001369, 119410001370
11 00732094259315117130559201 UDI/DI 00732094259315, Serial Numbers: 117130559201
12 00732094259322117350583998117500601523 UDI/DI 00732094259322, Serial Numbers: 117350583998, 117500601523
13 00732094259346116110347146116110347144 UDI/DI 00732094259346, Serial Numbers: 116110347146, 116110347144
14 00732094259445116430533831116430533832 UDI/DI 00732094259445, Serial Numbers: 116430533831, 116430533832
15 00732094259506116380527134117410589558118250001761119040000115119060000844119060000845123190000729123280000483123310000806123310000807123310000808123310000809123310000810123310000811123310000812123310000813123310000814123310000815123360000284123360000285123450001526123310000809123310000811123310000812123310000815 UDI/DI 00732094259506, Serial Numbers: 116380527134, 117410589558, 118250001761, 119040000115, 119060000844, 119060000845, 123190000729, 123280000483, 123310000806, 123310000807, 123310000808, 123310000809, 123310000810, 123310000811, 123310000812, 123310000813, 123310000814, 123310000815, 123360000284, 123360000285, 123450001526, 123310000809, 123310000811, 123310000812, 123310000815
16 00732094259575118250001384118260000794118390001821118480000848118480000849119060000841119060000842119090000727119100000033119150000332119240000238119240000239119240000240119250000166120010000573120290000988121400001929121430000537122050000996122090000520122090000521122090000522122090000523122090000524122090000525122090000526122090000527122090000528122170001299123250001020123340000589123520000414124060000807118480000848124060000807124170000873124170000874124170000875124170000876124170000877124170000878124170000879124170000880124170000881124170000882124280000135124280000136124280000137124280000138124280000139124320001530 UDI/DI 00732094259575, Serial Numbers: 118250001384, 118260000794, 118390001821, 118480000848, 118480000849, 119060000841, 119060000842, 119090000727, 119100000033, 119150000332, 119240000238, 119240000239, 119240000240, 119250000166, 120010000573, 120290000988, 121400001929, 121430000537, 122050000996, 122090000520, 122090000521, 122090000522, 122090000523, 122090000524, 122090000525, 122090000526, 122090000527, 122090000528, 122170001299, 123250001020, 123340000589, 123520000414, 124060000807, 118480000848, 124060000807, 124170000873, 124170000874, 124170000875, 124170000876, 124170000877, 124170000878, 124170000879, 124170000880, 124170000881, 124170000882, 124280000135, 124280000136, 124280000137, 124280000138, 124280000139, 124320001530
17 00732094259612116120365528 UDI/DI 00732094259612, Serial Numbers: 116120365528
18 00732094259650116240458430117220570917118120622072118170632918118180634236118300000863118330000273118330000274118420000151118440001977118480000847118520000564119170000630119270000360119270000361119270000362119350003349119380001118119380001119119430000811119340002163119470001921120050001766120050001767120050001768120130001344120140002540120180001090120180001094120220000883120320001828120330000906120380000317120450001959120450001960120450001961120450001962120460002493120460002494121070000871121130001178121150000446121190000645121200001260121200001261121230001203121230001205121280001926121290000365121290000366121370002519121370002520121370002521121370002522121370002523121370002524121380000290121380000291121380000292121380000293121380000294121380000295121380000296121380000297121380000298121380000299121380000300122020001217122020001218122020001219122020001220122020001221122020001222122070000778122070000779122070000780122070000781122080000291122120002598122120002599122120002600122140000214122220001051122250001505122470000642122470000643122470000644122470000645122470000646122470000647122470000648122470000649122470000650122470000651123060000583123060000584123060000585123060000586123060000587123060000588123060000589123060000590123060000591123130000065123150000926123210000750123250001018123250001019123320000674123430000969124010000937124060000806120180001093121010002477123060000586123250001019123320000674123430000969124010000937124060000806124150000052124150000053124150000054124150000055124150000056124150000057124150000058124150000059124150000060124150000061124180000273124220000141124220000142 UDI/DI 00732094259650, Serial Numbers: 116240458430, 117220570917, 118120622072, 118170632918, 118180634236, 118300000863, 118330000273, 118330000274, 118420000151, 118440001977, 118480000847, 118520000564, 119170000630, 119270000360, 119270000361, 119270000362, 119350003349, 119380001118, 119380001119, 119430000811, 119340002163, 119470001921, 120050001766, 120050001767, 120050001768, 120130001344, 120140002540, 120180001090, 120180001094, 120220000883, 120320001828, 120330000906, 120380000317, 120450001959, 120450001960, 120450001961, 120450001962, 120460002493, 120460002494, 121070000871, 121130001178, 121150000446, 121190000645, 121200001260, 121200001261, 121230001203, 121230001205, 121280001926, 121290000365, 121290000366, 121370002519, 121370002520, 121370002521, 121370002522, 121370002523, 121370002524, 121380000290, 121380000291, 121380000292, 121380000293, 121380000294, 121380000295, 121380000296, 121380000297, 121380000298, 121380000299, 121380000300, 122020001217, 122020001218, 122020001219, 122020001220, 122020001221, 122020001222, 122070000778, 122070000779, 122070000780, 122070000781, 122080000291, 122120002598, 122120002599, 122120002600, 122140000214, 122220001051, 122250001505, 122470000642, 122470000643, 122470000644, 122470000645, 122470000646, 122470000647, 122470000648, 122470000649, 122470000650, 122470000651, 123060000583, 123060000584, 123060000585, 123060000586, 123060000587, 123060000588, 123060000589, 123060000590, 123060000591, 123130000065, 123150000926, 123210000750, 123250001018, 123250001019, 123320000674, 123430000969, 124010000937, 124060000806, 120180001093, 121010002477, 123060000586, 123250001019, 123320000674, 123430000969, 124010000937, 124060000806, 124150000052, 124150000053, 124150000054, 124150000055, 124150000056, 124150000057, 124150000058, 124150000059, 124150000060, 124150000061, 124180000273, 124220000141, 124220000142
19 00732094259681118520000552118520000554119470001920121060000078121370000332122100000410122130000800122220000669122220000670 UDI/DI 00732094259681, Serial Numbers: 118520000552, 118520000554, 119470001920, 121060000078, 121370000332, 122100000410, 122130000800, 122220000669, 122220000670
20 00732094259735118180635067118180635066118180635065 UDI/DI 00732094259735, Serial Numbers: 118180635067, 118180635066, 118180635065
Page 1 of 4
Amount recalled: 766 units

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Why it was recalled

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Other recalls from Baxter Healthcare Corporation

160 in total.

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`00732094259032115340269178117060553883117060553884117060553885119230003169`	UDI/DI 00732094259032, Serial Numbers: 115340269178, 117060553883, 117060553884, 117060553885, 119230003169
2	`00732094259070117130559202117130559203117130559204`	UDI/DI 00732094259070, Serial Numbers: 117130559202, 117130559203, 117130559204
3	`00732094259100116270497046117190567440`	UDI/DI 00732094259100, Serial Numbers: 116270497046, 117190567440
4	`00732094259148117350583961119060000843122090000529`	UDI/DI 00732094259148, Serial Numbers: 117350583961, 119060000843, 122090000529
5	`00732094259179116240458434116500543985120480000930`	UDI/DI 00732094259179, Serial Numbers: 116240458434, 116500543985, 120480000930
6	`00732094259230118160628177`	UDI/DI 00732094259230, Serial Numbers: 118160628177
7	`00732094259261117470596306`	UDI/DI 00732094259261, Serial Numbers: 117470596306
8	`00732094259285118100618358116110348774116490541753117430591185117510601740`	UDI/DI 00732094259285, Serial Numbers: 118100618358, 116110348774, 116490541753, 117430591185, 117510601740
9	`00732094259292116460537153118490000226`	UDI/DI 00732094259292, Serial Numbers: 116460537153, 118490000226
10	`00732094259308116120365527119410001349119410001350119410001351119410001352119410001353119410001354119410001355119410001356119410001357119410001358119410001359119410001360119410001361119410001362119410001363119410001364119410001365119410001366119410001367119410001368119410001369119410001370`	UDI/DI 00732094259308, Serial Numbers: 116120365527, 119410001349, 119410001350, 119410001351, 119410001352, 119410001353, 119410001354, 119410001355, 119410001356, 119410001357, 119410001358, 119410001359, 119410001360, 119410001361, 119410001362, 119410001363, 119410001364, 119410001365, 119410001366, 119410001367, 119410001368, 119410001369, 119410001370
11	`00732094259315117130559201`	UDI/DI 00732094259315, Serial Numbers: 117130559201
12	`00732094259322117350583998117500601523`	UDI/DI 00732094259322, Serial Numbers: 117350583998, 117500601523
13	`00732094259346116110347146116110347144`	UDI/DI 00732094259346, Serial Numbers: 116110347146, 116110347144
14	`00732094259445116430533831116430533832`	UDI/DI 00732094259445, Serial Numbers: 116430533831, 116430533832
15	`00732094259506116380527134117410589558118250001761119040000115119060000844119060000845123190000729123280000483123310000806123310000807123310000808123310000809123310000810123310000811123310000812123310000813123310000814123310000815123360000284123360000285123450001526123310000809123310000811123310000812123310000815`	UDI/DI 00732094259506, Serial Numbers: 116380527134, 117410589558, 118250001761, 119040000115, 119060000844, 119060000845, 123190000729, 123280000483, 123310000806, 123310000807, 123310000808, 123310000809, 123310000810, 123310000811, 123310000812, 123310000813, 123310000814, 123310000815, 123360000284, 123360000285, 123450001526, 123310000809, 123310000811, 123310000812, 123310000815
16	`00732094259575118250001384118260000794118390001821118480000848118480000849119060000841119060000842119090000727119100000033119150000332119240000238119240000239119240000240119250000166120010000573120290000988121400001929121430000537122050000996122090000520122090000521122090000522122090000523122090000524122090000525122090000526122090000527122090000528122170001299123250001020123340000589123520000414124060000807118480000848124060000807124170000873124170000874124170000875124170000876124170000877124170000878124170000879124170000880124170000881124170000882124280000135124280000136124280000137124280000138124280000139124320001530`	UDI/DI 00732094259575, Serial Numbers: 118250001384, 118260000794, 118390001821, 118480000848, 118480000849, 119060000841, 119060000842, 119090000727, 119100000033, 119150000332, 119240000238, 119240000239, 119240000240, 119250000166, 120010000573, 120290000988, 121400001929, 121430000537, 122050000996, 122090000520, 122090000521, 122090000522, 122090000523, 122090000524, 122090000525, 122090000526, 122090000527, 122090000528, 122170001299, 123250001020, 123340000589, 123520000414, 124060000807, 118480000848, 124060000807, 124170000873, 124170000874, 124170000875, 124170000876, 124170000877, 124170000878, 124170000879, 124170000880, 124170000881, 124170000882, 124280000135, 124280000136, 124280000137, 124280000138, 124280000139, 124320001530
17	`00732094259612116120365528`	UDI/DI 00732094259612, Serial Numbers: 116120365528
18	`00732094259650116240458430117220570917118120622072118170632918118180634236118300000863118330000273118330000274118420000151118440001977118480000847118520000564119170000630119270000360119270000361119270000362119350003349119380001118119380001119119430000811119340002163119470001921120050001766120050001767120050001768120130001344120140002540120180001090120180001094120220000883120320001828120330000906120380000317120450001959120450001960120450001961120450001962120460002493120460002494121070000871121130001178121150000446121190000645121200001260121200001261121230001203121230001205121280001926121290000365121290000366121370002519121370002520121370002521121370002522121370002523121370002524121380000290121380000291121380000292121380000293121380000294121380000295121380000296121380000297121380000298121380000299121380000300122020001217122020001218122020001219122020001220122020001221122020001222122070000778122070000779122070000780122070000781122080000291122120002598122120002599122120002600122140000214122220001051122250001505122470000642122470000643122470000644122470000645122470000646122470000647122470000648122470000649122470000650122470000651123060000583123060000584123060000585123060000586123060000587123060000588123060000589123060000590123060000591123130000065123150000926123210000750123250001018123250001019123320000674123430000969124010000937124060000806120180001093121010002477123060000586123250001019123320000674123430000969124010000937124060000806124150000052124150000053124150000054124150000055124150000056124150000057124150000058124150000059124150000060124150000061124180000273124220000141124220000142`	UDI/DI 00732094259650, Serial Numbers: 116240458430, 117220570917, 118120622072, 118170632918, 118180634236, 118300000863, 118330000273, 118330000274, 118420000151, 118440001977, 118480000847, 118520000564, 119170000630, 119270000360, 119270000361, 119270000362, 119350003349, 119380001118, 119380001119, 119430000811, 119340002163, 119470001921, 120050001766, 120050001767, 120050001768, 120130001344, 120140002540, 120180001090, 120180001094, 120220000883, 120320001828, 120330000906, 120380000317, 120450001959, 120450001960, 120450001961, 120450001962, 120460002493, 120460002494, 121070000871, 121130001178, 121150000446, 121190000645, 121200001260, 121200001261, 121230001203, 121230001205, 121280001926, 121290000365, 121290000366, 121370002519, 121370002520, 121370002521, 121370002522, 121370002523, 121370002524, 121380000290, 121380000291, 121380000292, 121380000293, 121380000294, 121380000295, 121380000296, 121380000297, 121380000298, 121380000299, 121380000300, 122020001217, 122020001218, 122020001219, 122020001220, 122020001221, 122020001222, 122070000778, 122070000779, 122070000780, 122070000781, 122080000291, 122120002598, 122120002599, 122120002600, 122140000214, 122220001051, 122250001505, 122470000642, 122470000643, 122470000644, 122470000645, 122470000646, 122470000647, 122470000648, 122470000649, 122470000650, 122470000651, 123060000583, 123060000584, 123060000585, 123060000586, 123060000587, 123060000588, 123060000589, 123060000590, 123060000591, 123130000065, 123150000926, 123210000750, 123250001018, 123250001019, 123320000674, 123430000969, 124010000937, 124060000806, 120180001093, 121010002477, 123060000586, 123250001019, 123320000674, 123430000969, 124010000937, 124060000806, 124150000052, 124150000053, 124150000054, 124150000055, 124150000056, 124150000057, 124150000058, 124150000059, 124150000060, 124150000061, 124180000273, 124220000141, 124220000142
19	`00732094259681118520000552118520000554119470001920121060000078121370000332122100000410122130000800122220000669122220000670`	UDI/DI 00732094259681, Serial Numbers: 118520000552, 118520000554, 119470001920, 121060000078, 121370000332, 122100000410, 122130000800, 122220000669, 122220000670
20	`00732094259735118180635067118180635066118180635065`	UDI/DI 00732094259735, Serial Numbers: 118180635067, 118180635066, 118180635065