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
#BarcodesProduct as published
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200732094263046118460001965119150000243119390000178119390000179119500000539120480001168121030000268121130001324121270000249121380000289121480000761121480000762121480000763121480000764121480000765121480000766121480000767121480000768121480000769121480000770121480000771121490000809121490000810121490000811121370002215122020001003122020001004122020001005122020001006122020001007122020001008122020001009122020001010122020001011122020001012122020001013122050001754122050001755122050001756122050001757122050001758122050001759122040000338122040000339122040000341122050000662122050000667122120002583122120002584122120002585122120002586122120002587122120002588122120002589122120002590122120002591122120002592122120002593122120002594122160000170122160000171122160000172122200000716122200000717122200000718122200000719123060000574123060000575123060000576123060000577123060000578123060000579123060000580123060000581123060000582123100001462123100001463122450001687122450001690122450001691122450001693122120002594122200000716123060000576123060000578123060000581123060000582123320000688123320000689UDI/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
300732094263107116440534586116440534587116440534588116440534589116440534590116440534591116440534592116440534593116440534594116440534595116440534596116440534597116440534598116440534599116440534600117010549214117010549215117010549216117010549217117010549218117010549219117010549220117010549221117010549222117010549223117130559079117130559080117130559081117130559082117130559083117130559084117130559085117130559086117130559087117130559088117130559089117130559090117130559091117130559092117130559093117270577247117270577248117270577249117270577250117270577251117270577252117270577253117270577254117270577255117270577256117360584807117360584808117360584809117360584810117360584811117360584812117360584813117360584814117360584815117360584816118110619366118110619367118110619368118110619369118110619370118110619371118110619372118110619373118110619374118110619375118450001287118450001288118450001289118450001290118450001291118450001292118450001293118450001294118450001295118450001296119240000205119240000206119240000207119240000208119240000209119240000210119240000211119240000212119240000213119240000214119240000216119240000217119240000218119240000219119240000220119240000221119240000222119240000223119240000224119240000225119300001280119300001281119300001282119300001283119300001284119300001285119300001286119300001287119300001288119300001289121030000675121030000676121030000677121030000678121030000679121030000680121030000681121030000682121030000683121030000684121040000881121040000882121040000883121040000884121040000885121040000886121040000887121040000888121040000889121040000890121060000036121060000037121060000038121060000039121060000040121060000041121060000042121060000043121060000044121060000045121410001269121410001270121410001271121410001272121410001273121410001274121410001275121410001276121410001277121410001278121410001279121410001280121410001281121410001282121410001283121410001284121410001285121410001286121410001287121410001288122280000939122280000940122280000941122280000942122280000943122280000944122280000945122280000946122280000947122280000948122280000949122280000950122280000951122280000952122280000953122280000954122280000955122280000956122280000957122280000958122280000959122280000960122280000961122280000962122280000963122280000964122280000965122280000966122280000967122280000968122520001054122520001055122520001056122520001057122520001058122520001059122520001060122520001061122520001062122520001063123010000269123010000270123010000271123010000272123010000273123010000274123010000275123010000276123010000277123010000278122520001054UDI/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
400732094263138UDI/DI 00732094263138, Serial Numbers: 1, 2
500732094263152117500601521UDI/DI 00732094263152, Serial Numbers: 117500601521
600732094263169118120622041118120622040118120622039118120622038118120622037118120622036118120622035118120622034118120622033118120622032UDI/DI 00732094263169, Serial Numbers: 118120622041, 118120622040, 118120622039, 118120622038, 118120622037, 118120622036, 118120622035, 118120622034, 118120622033, 118120622032
700812345027822116270501517117270576947UDI/DI 00812345027822, Serial Numbers: 116270501517, 117270576947
800812345027839116270499720116290516803116480540314117050553486117050553487117110556359117170566163117170566164117170566165117170566166117170566167117170566168117170566169117170566171117170566172117170566170117340583183117340583184117340583185117340583186117340583187117340583188117340583189117340583190117340583191117340583192117350584681116270499720UDI/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
900817655020280116420532965116450536831116460538001117010549242117260576252117260576918117430592085117430592086117430592087117430592088117430592083UDI/DI 00817655020280, Serial Numbers: 116420532965, 116450536831, 116460538001, 117010549242, 117260576252, 117260576918, 117430592085, 117430592086, 117430592087, 117430592088, 117430592083
1000817655021362117130560315117130560316117130560317UDI/DI 00817655021362, Serial Numbers: 117130560315, 117130560316, 117130560317
1100817655022246118390000403UDI/DI 00817655022246, Serial Numbers: 118390000403
12117220571712117290578777117290578778117290578779117290578780117290578781117290578782UDI/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.

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.