Reported Nov 13, 2024 · Ongoing
Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
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 RScribe 12-Lead Electrocardiograph System; Electrocardiograph
- Lot codes and dates
12 of 12 products
Products covered by this recall # Barcodes Product as published 1 00732094262957118100617841118250001722118480000511119140000676119150000331119180000544119180000545119180000546119180000547119180000548119180000549119180000550119180000551119340002011119340002012119460000996119470001912120110000469120130001657120160001284120420002132120420002133120420002134120420002135120420002136121330000576121330000577121330000578121330000579121330000580121330000581121330000582121390000797UDI/DI 00732094262957, Serial Numbers: 118100617841, 118250001722, 118480000511, 119140000676, 119150000331, 119180000544, 119180000545, 119180000546, 119180000547, 119180000548, 119180000549, 119180000550, 119180000551, 119340002011, 119340002012, 119460000996, 119470001912, 120110000469, 120130001657, 120160001284, 120420002132, 120420002133, 120420002134, 120420002135, 120420002136, 121330000576, 121330000577, 121330000578, 121330000579, 121330000580, 121330000581, 121330000582, 121390000797 2 00732094263046118460001965119150000243119390000178119390000179119500000539120480001168121030000268121130001324121270000249121380000289121480000761121480000762121480000763121480000764121480000765121480000766121480000767121480000768121480000769121480000770121480000771121490000809121490000810121490000811121370002215122020001003122020001004122020001005122020001006122020001007122020001008122020001009122020001010122020001011122020001012122020001013122050001754122050001755122050001756122050001757122050001758122050001759122040000338122040000339122040000341122050000662122050000667122120002583122120002584122120002585122120002586122120002587122120002588122120002589122120002590122120002591122120002592122120002593122120002594122160000170122160000171122160000172122200000716122200000717122200000718122200000719123060000574123060000575123060000576123060000577123060000578123060000579123060000580123060000581123060000582123100001462123100001463122450001687122450001690122450001691122450001693122120002594122200000716123060000576123060000578123060000581123060000582123320000688123320000689UDI/DI 00732094263046, Serial Numbers: 118460001965, 119150000243, 119390000178, 119390000179, 119500000539, 120480001168, 9069365, 121030000268, 121130001324, 121270000249, 121380000289, 121480000761, 121480000762, 121480000763, 121480000764, 121480000765, 121480000766, 121480000767, 121480000768, 121480000769, 121480000770, 121480000771, 121490000809, 121490000810, 121490000811, 121370002215, 122020001003, 122020001004, 122020001005, 122020001006, 122020001007, 122020001008, 122020001009, 122020001010, 122020001011, 122020001012, 122020001013, 122050001754, 122050001755, 122050001756, 122050001757, 122050001758, 122050001759, 122040000338, 122040000339, 122040000341, 122050000662, 122050000667, 122120002583, 122120002584, 122120002585, 122120002586, 122120002587, 122120002588, 122120002589, 122120002590, 122120002591, 122120002592, 122120002593, 122120002594, 122160000170, 122160000171, 122160000172, 122200000716, 122200000717, 122200000718, 122200000719, 123060000574, 123060000575, 123060000576, 123060000577, 123060000578, 123060000579, 123060000580, 123060000581, 123060000582, 123100001462, 123100001463, 122450001687, 122450001690, 122450001691, 122450001693, 122120002594, 122200000716, 123060000576, 123060000578, 123060000581, 123060000582, 123320000688, 123320000689 3 00732094263107116440534586116440534587116440534588116440534589116440534590116440534591116440534592116440534593116440534594116440534595116440534596116440534597116440534598116440534599116440534600117010549214117010549215117010549216117010549217117010549218117010549219117010549220117010549221117010549222117010549223117130559079117130559080117130559081117130559082117130559083117130559084117130559085117130559086117130559087117130559088117130559089117130559090117130559091117130559092117130559093117270577247117270577248117270577249117270577250117270577251117270577252117270577253117270577254117270577255117270577256117360584807117360584808117360584809117360584810117360584811117360584812117360584813117360584814117360584815117360584816118110619366118110619367118110619368118110619369118110619370118110619371118110619372118110619373118110619374118110619375118450001287118450001288118450001289118450001290118450001291118450001292118450001293118450001294118450001295118450001296119240000205119240000206119240000207119240000208119240000209119240000210119240000211119240000212119240000213119240000214119240000216119240000217119240000218119240000219119240000220119240000221119240000222119240000223119240000224119240000225119300001280119300001281119300001282119300001283119300001284119300001285119300001286119300001287119300001288119300001289121030000675121030000676121030000677121030000678121030000679121030000680121030000681121030000682121030000683121030000684121040000881121040000882121040000883121040000884121040000885121040000886121040000887121040000888121040000889121040000890121060000036121060000037121060000038121060000039121060000040121060000041121060000042121060000043121060000044121060000045121410001269121410001270121410001271121410001272121410001273121410001274121410001275121410001276121410001277121410001278121410001279121410001280121410001281121410001282121410001283121410001284121410001285121410001286121410001287121410001288122280000939122280000940122280000941122280000942122280000943122280000944122280000945122280000946122280000947122280000948122280000949122280000950122280000951122280000952122280000953122280000954122280000955122280000956122280000957122280000958122280000959122280000960122280000961122280000962122280000963122280000964122280000965122280000966122280000967122280000968122520001054122520001055122520001056122520001057122520001058122520001059122520001060122520001061122520001062122520001063123010000269123010000270123010000271123010000272123010000273123010000274123010000275123010000276123010000277123010000278122520001054UDI/DI 00732094263107, Serial Numbers: 116440534586, 116440534587, 116440534588, 116440534589, 116440534590, 116440534591, 116440534592, 116440534593, 116440534594, 116440534595, 116440534596, 116440534597, 116440534598, 116440534599, 116440534600, 117010549214, 117010549215, 117010549216, 117010549217, 117010549218, 117010549219, 117010549220, 117010549221, 117010549222, 117010549223, 117130559079, 117130559080, 117130559081, 117130559082, 117130559083, 117130559084, 117130559085, 117130559086, 117130559087, 117130559088, 117130559089, 117130559090, 117130559091, 117130559092, 117130559093, 117270577247, 117270577248, 117270577249, 117270577250, 117270577251, 117270577252, 117270577253, 117270577254, 117270577255, 117270577256, 117360584807, 117360584808, 117360584809, 117360584810, 117360584811, 117360584812, 117360584813, 117360584814, 117360584815, 117360584816, 118110619366, 118110619367, 118110619368, 118110619369, 118110619370, 118110619371, 118110619372, 118110619373, 118110619374, 118110619375, 118450001287, 118450001288, 118450001289, 118450001290, 118450001291, 118450001292, 118450001293, 118450001294, 118450001295, 118450001296, 119240000205, 119240000206, 119240000207, 119240000208, 119240000209, 119240000210, 119240000211, 119240000212, 119240000213, 119240000214, 119240000216, 119240000217, 119240000218, 119240000219, 119240000220, 119240000221, 119240000222, 119240000223, 119240000224, 119240000225, 119300001280, 119300001281, 119300001282, 119300001283, 119300001284, 119300001285, 119300001286, 119300001287, 119300001288, 119300001289, 121030000675, 121030000676, 121030000677, 121030000678, 121030000679, 121030000680, 121030000681, 121030000682, 121030000683, 121030000684, 121040000881, 121040000882, 121040000883, 121040000884, 121040000885, 121040000886, 121040000887, 121040000888, 121040000889, 121040000890, 121060000036, 121060000037, 121060000038, 121060000039, 121060000040, 121060000041, 121060000042, 121060000043, 121060000044, 121060000045, 121410001269, 121410001270, 121410001271, 121410001272, 121410001273, 121410001274, 121410001275, 121410001276, 121410001277, 121410001278, 121410001279, 121410001280, 121410001281, 121410001282, 121410001283, 121410001284, 121410001285, 121410001286, 121410001287, 121410001288, 122280000939, 122280000940, 122280000941, 122280000942, 122280000943, 122280000944, 122280000945, 122280000946, 122280000947, 122280000948, 122280000949, 122280000950, 122280000951, 122280000952, 122280000953, 122280000954, 122280000955, 122280000956, 122280000957, 122280000958, 122280000959, 122280000960, 122280000961, 122280000962, 122280000963, 122280000964, 122280000965, 122280000966, 122280000967, 122280000968, 122520001054, 122520001055, 122520001056, 122520001057, 122520001058, 122520001059, 122520001060, 122520001061, 122520001062, 122520001063, 123010000269, 123010000270, 123010000271, 123010000272, 123010000273, 123010000274, 123010000275, 123010000276, 123010000277, 123010000278, 122520001054 4 00732094263138UDI/DI 00732094263138, Serial Numbers: 1, 2 5 00732094263152117500601521UDI/DI 00732094263152, Serial Numbers: 117500601521 6 00732094263169118120622041118120622040118120622039118120622038118120622037118120622036118120622035118120622034118120622033118120622032UDI/DI 00732094263169, Serial Numbers: 118120622041, 118120622040, 118120622039, 118120622038, 118120622037, 118120622036, 118120622035, 118120622034, 118120622033, 118120622032 7 00812345027822116270501517117270576947UDI/DI 00812345027822, Serial Numbers: 116270501517, 117270576947 8 00812345027839116270499720116290516803116480540314117050553486117050553487117110556359117170566163117170566164117170566165117170566166117170566167117170566168117170566169117170566171117170566172117170566170117340583183117340583184117340583185117340583186117340583187117340583188117340583189117340583190117340583191117340583192117350584681116270499720UDI/DI 00812345027839, Serial Numbers: 116270499720, 116290516803, 116480540314, 117050553486, 117050553487, 117110556359, 117170566163, 117170566164, 117170566165, 117170566166, 117170566167, 117170566168, 117170566169, 117170566171, 117170566172, 117170566170, 117340583183, 117340583184, 117340583185, 117340583186, 117340583187, 117340583188, 117340583189, 117340583190, 117340583191, 117340583192, 117350584681, 116270499720 9 00817655020280116420532965116450536831116460538001117010549242117260576252117260576918117430592085117430592086117430592087117430592088117430592083UDI/DI 00817655020280, Serial Numbers: 116420532965, 116450536831, 116460538001, 117010549242, 117260576252, 117260576918, 117430592085, 117430592086, 117430592087, 117430592088, 117430592083 10 00817655021362117130560315117130560316117130560317UDI/DI 00817655021362, Serial Numbers: 117130560315, 117130560316, 117130560317 11 00817655022246118390000403UDI/DI 00817655022246, Serial Numbers: 118390000403 12 117220571712117290578777117290578778117290578779117290578780117290578781117290578782UDI/DI none, Serial Numbers: 117220571712, 117290578777, 117290578778, 117290578779, 117290578780, 117290578781, 117290578782 - Amount recalled
- 399 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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