Reported Nov 13, 2024 · Ongoing
Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
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 Q-Stress Cardiac Stress Testing System; cardiac stress test
- Lot codes and dates
36 of 36 products
Products covered by this recall # Barcodes Product as published 1 00732094263213117240573990117360584950UDI/DI 00732094263213, Serial Numbers: 117240573990, 117360584950 2 00732094263237117500600524122410000834UDI/DI 00732094263237, Serial Numbers: 117500600524, 122410000834 3 00732094263336118110620686UDI/DI 00732094263336, Serial Numbers: 118110620686 4 00732094263374116520545398116520545399117050553501117050553502117170565092117170565093117170565094117170565095117170565096118090616242118090616243118170632609118170632608118100617936118100617935118100617934118340000113118340000114118340000115118340000116118340000117118340000118118340000119118450001233118450001234118450001235118450001236118450001237118450001238118450001239118450001240118450001241119330000811119330000812119330000813119330000814119330000815119330000816119330000817119330000818119330000819119330000820119330000821120010000185120010000186120010000187120010000188120010000189120110000599120110000600120110000601120110000602120110000603121050000579121050000580121410001265121410001266121410001267121410001268122460001565122460001566122460001567123370000157123370000158UDI/DI 00732094263374, Serial Numbers: 116520545398, 116520545399, 117050553501, 117050553502, 117170565092, 117170565093, 117170565094, 117170565095, 117170565096, 118090616242, 118090616243, 118170632609, 118170632608, 118100617936, 118100617935, 118100617934, 118340000113, 118340000114, 118340000115, 118340000116, 118340000117, 118340000118, 118340000119, 118450001233, 118450001234, 118450001235, 118450001236, 118450001237, 118450001238, 118450001239, 118450001240, 118450001241, 119330000811, 119330000812, 119330000813, 119330000814, 119330000815, 119330000816, 119330000817, 119330000818, 119330000819, 119330000820, 119330000821, 120010000185, 120010000186, 120010000187, 120010000188, 120010000189, 120110000599, 120110000600, 120110000601, 120110000602, 120110000603, 121050000579, 121050000580, 121410001265, 121410001266, 121410001267, 121410001268, 122460001565, 122460001566, 122460001567, 123370000157, 123370000158 5 00732094263381116160400812116160400841116160400843116160400845116400529512116400529513116400530030116400530031116400530032116450536621116450536622UDI/DI 00732094263381, Serial Numbers: 116160400812, 116160400841, 116160400843, 116160400845, 116400529512, 116400529513, 116400530030, 116400530031, 116400530032, 116450536621, 116450536622 6 00732094263398118110620685118210639085UDI/DI 00732094263398, Serial Numbers: 118110620685, 118210639085 7 00732094263411117290578773UDI/DI 00732094263411, Serial Numbers: 117290578773 8 00732094263428116120375032116120375035117060553847117120556934117120556935120330000900120360000449122360000839122490000191122490000192UDI/DI 00732094263428, Serial Numbers: 116120375032, 116120375035, 117060553847, 117120556934, 117120556935, 120330000900, 120360000449, 122360000839, 122490000191, 122490000192 9 00732094263435117310581163UDI/DI 00732094263435, Serial Numbers: 117310581163 10 00732094263626116170410170UDI/DI 00732094263626, Serial Numbers: 116170410170 11 00732094263671120050000514UDI/DI 00732094263671, Serial Numbers: 120050000514 12 00732094263879116500544081116500544082116500544083117050553074117050553075117050553076117380587626117380587627117460595385117460595386117460595387117460595388117460595389117460595390118090616424118090616425118090616426118170632607118170632606118100617938118100617937118460000409118460000410118460000411118460000412118460000413118460000414121050000574121050000575121050000576121050000577121050000578121110000824121110000825121110000826121110000827121110000828121110000829121110000830121110000831121110000832121110000833121110000834121110000835121110000836121170000411121170000412121170000413121170000414121170000415121170000416121170000417121240001237121240001238121370000463121370000464121370000465121370000466121370000467121410001255121410001256121410001257121410001258121410001259121410001260121410001261121410001262121410001263121410001264122460001573122460001574122460001575122460001576122460001577123030001336123030001337123030001338123030001339123030001340123030001341123030001342123030001343123030001344123030001345123030001346123030001347123200001027123200001028123200001029123200001030123200001031123200001032123250001021123250001022123250001023123250001024123250001025123250001026123280000365123280000366123280000367123280000368123280000369123280000370123370000153123370000154123370000155123370000156123480000934123480000935123480000936121370000466124110000985124160001082124160001083124160002095124160002096124160002097124160002098124160002099124160002100124160002101124160002102124160002103124160002104124160002105124160002106124160002107124160002108124160002109124160002110124160002111124160002112124160002113124160002114UDI/DI 00732094263879, Serial Numbers: 116500544081, 116500544082, 116500544083, 117050553074, 117050553075, 117050553076, 117380587626, 117380587627, 117460595385, 117460595386, 117460595387, 117460595388, 117460595389, 117460595390, 118090616424, 118090616425, 118090616426, 118170632607, 118170632606, 118100617938, 118100617937, 118460000409, 118460000410, 118460000411, 118460000412, 118460000413, 118460000414, 121050000574, 121050000575, 121050000576, 121050000577, 121050000578, 121110000824, 121110000825, 121110000826, 121110000827, 121110000828, 121110000829, 121110000830, 121110000831, 121110000832, 121110000833, 121110000834, 121110000835, 121110000836, 121170000411, 121170000412, 121170000413, 121170000414, 121170000415, 121170000416, 121170000417, 121240001237, 121240001238, 121370000463, 121370000464, 121370000465, 121370000466, 121370000467, 121410001255, 121410001256, 121410001257, 121410001258, 121410001259, 121410001260, 121410001261, 121410001262, 121410001263, 121410001264, 122460001573, 122460001574, 122460001575, 122460001576, 122460001577, 123030001336, 123030001337, 123030001338, 123030001339, 123030001340, 123030001341, 123030001342, 123030001343, 123030001344, 123030001345, 123030001346, 123030001347, 123200001027, 123200001028, 123200001029, 123200001030, 123200001031, 123200001032, 123250001021, 123250001022, 123250001023, 123250001024, 123250001025, 123250001026, 123280000365, 123280000366, 123280000367, 123280000368, 123280000369, 123280000370, 123370000153, 123370000154, 123370000155, 123370000156, 123480000934, 123480000935, 123480000936, 121370000466, 124110000985, 124160001082, 124160001083, 124160002095, 124160002096, 124160002097, 124160002098, 124160002099, 124160002100, 124160002101, 124160002102, 124160002103, 124160002104, 124160002105, 124160002106, 124160002107, 124160002108, 124160002109, 124160002110, 124160002111, 124160002112, 124160002113, 124160002114 13 00732094263893118070613221120390000393122240001151UDI/DI 00732094263893, Serial Numbers: 118070613221, 120390000393, 122240001151 14 00732094263930116150390528UDI/DI 00732094263930, Serial Numbers: 116150390528 15 00732094263947115510284680115510284694119240000738UDI/DI 00732094263947, Serial Numbers: 115510284680, 115510284694, 119240000738 16 00732094289169118290001244118460002309118480000818UDI/DI 00732094289169, Serial Numbers: 118290001244, 118460002309, 118480000818 17 00732094296273118380000431UDI/DI 00732094296273, Serial Numbers: 118380000431 18 00732094308426122480001104123270000832UDI/DI 00732094308426, Serial Numbers: 122480001104, 123270000832 19 00732094309645119080001407119080001408UDI/DI 00732094309645, Serial Numbers: 119080001407, 119080001408 20 00732094312898119470002281119470002281UDI/DI 00732094312898, Serial Numbers: 119470002281, 119470002281 - Amount recalled
- 2461 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.
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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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