CLASS II ONGOING Device recall · Reported 13 Nov 2024 · FDA Enforcement Report
Hillrom Welch Allyn XScribe Cardiac Stress Testing System recalled
Baxter Healthcare is recalling Hillrom Welch Allyn XScribe Cardiac Stress Testing System. The recall was initiated on 11 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0325-2025
- FDA event ID
- 95559
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Oct 2024
- FDA classified
- 7 Nov 2024
- Reported
- 13 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Oct 2024 | Recall initiated by company | |
| 7 Nov 2024 | Classified by FDA | +27 days |
| 13 Nov 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
Software Versions: Software Version V6.0.0 V6.3.2, Release Date 02-Jul-2015 Units: 1) UDI/DI 00732094259032, Serial Numbers: 115340269178, 117060553883, 117060553884, 117060553885, 119230003169; 2) UDI/DI 00732094259070, Serial Numbers: 117130559202, 117130559203, 117130559204; 3) UDI/DI 00732094259100, Serial Numbers: 116270497046, 117190567440; 4) UDI/DI 00732094259148, Serial Numbers: 117350583961, 119060000843, 122090000529; 5) UDI/DI 00732094259179, Serial Numbers: 116240458434, 116500543985, 120480000930; 6) UDI/DI 00732094259230, Serial Numbers: 118160628177; 7) UDI/DI 00732094259261, Serial Numbers: 117470596306; 8) UDI/DI 00732094259285, Serial Numbers: 118100618358, 116110348774, 116490541753, 117430591185, 117510601740; 9) UDI/DI 00732094259292, Serial Numbers: 116460537153, 118490000226; 10) 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) UDI/DI 00732094259315, Serial Numbers: 117130559201; 12) UDI/DI 00732094259322, Serial Numbers: 117350583998, 117500601523; 13) UDI/DI 00732094259346, Serial Numbers: 116110347146, 116110347144; 14) UDI/DI 00732094259445, Serial Numbers: 116430533831, 116430533832; 15) 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) 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) UDI/DI 00732094259612, Serial Numbers: 116120365528; 18) 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) UDI/DI 00732094259681, Serial Numbers: 118520000552, 118520000554, 119470001920, 121060000078, 121370000332, 122100000410, 122130000800, 122220000669, 122220000670; 20) UDI/DI 00732094259735, Serial Numbers: 118180635067, 118180635066, 118180635065; 21) UDI/DI 00732094259766, Serial Numbers: 118190636601, 118190636602, 118190636603, 118190636604, 118190636605, 118480000844, 118480000845; 22) UDI/DI 00732094259810, Serial Numbers: 118180635071, 118180635070, 118180635069, 118180635068, 119090000517, 119090000518, 122440001777, 124100001981, 124100001982; 23) UDI/DI 00732094259889, Serial Numbers: 117390588078; 24) UDI/DI 00732094259919, Serial Numbers: 116460538218, 116460538215, 116460538216, 116460538217; 25) UDI/DI 00732094259971, Serial Numbers: 118130624172, 118130624171, 118130624170, 118130624169; 26) UDI/DI 00732094260120, Serial Numbers: 116500544084, 119250000576, 120180001429; 27) UDI/DI 00732094260137, Serial Numbers: 117380586599, 117380586600; 28) UDI/DI 00732094260151, Serial Numbers: 117160563860, 117160563861, 117160563861; 29) UDI/DI 00732094260199, Serial Numbers: 117510602780, 117510602781; 30) UDI/DI 00732094260229, Serial Numbers: 116490541264, 116490541265, 117120557428, 117110556357, 117110556358, 117120557429, 119090000904, 119160000011, 121420001250, 121420001251, 121420001252, 122020000514, 122040000388, 122040000389, 122160000173, 122270001144, 122270001145, 122270001146, 122310000679, 122330000876, 122340000460, 122480000518, 123170000268; 31) UDI/DI 00732094260267, Serial Numbers: 116470539357, 116470539358, 116470539359, 116470539360, 116470539361, 116470539362, 116470539363, 116470539364, 116470539365, 116470539366, 116470539367, 116470539368, 118140625738, 119020000217, 119020000218, 119020000219, 119130001319, 119130001320, 119130001321, 119460001369, 121320001536, 123240001506, 123240001507, 124200000349; 32) UDI/DI 00732094260304, Serial Numbers: 117140562699, 117140562700; 33) UDI/DI 00732094260342, Serial Numbers: 116510545162; 34) UDI/DI 00732094260380, Serial Numbers: 116070308454, 116480540034, 118300000033, 118300000034, 118300000035, 118300000036, 118300000037, 118300000038, 118300000039, 118300000041, 118300000042, 118300000043, 118300000044, 118300000045, 118300000046, 118300000047, 118300000048, 118300000049, 118300000050, 118300000051, 118300000052, 118300000053, 118300000054, 118300000055, 118340000935, 118340000936, 118340000937, 118340000938, 118340000939, 118340000940, 118340000941, 118340000942, 118340000943, 118460001733, 118460001734, 119240000094, 120190001967, 120190001968, 120190001969, 120220001542, 120220001543, 120220001544, 120220001545, 120220001546, 122070001255, 118300000053, 118300000055, 120220001542; 35) UDI/DI 00732094260434, Serial Numbers: 118300000860, 118460001730, 118460001732, 118480000841, 119130000112, 119130000113, 119130000114, 119200001280, 119200001614, 119380001489, 121150000434, 121150000435, 121360000218, 121450000733, 121520000986, 121520000987, 121520000988, 121520000989, 119380001489; 36) UDI/DI 00732094260519, Serial Numbers: 113030149726, 113030149727, 118120623345, 114160206692, 115170254512, 115170254513, 117270576959, 118230000780, 118240001065, 118240001637, 118300000859, 118330001333, 118440000169, 118480000837, 119060000839, 119090000902, 119170000481, 119170000482, 119170000483, 119170000484, 119170000485, 119200000583, 119200001823, 119230002791, 119250000575, 119380001481, 119380001482, 119490000072, 119490000073, 120220000881, 120220000882, 120290000977, 120290000978, 120520000902, 121230000437, 121250001830, 122050000686, 122050000687, 122070000773, 122070000774, 122070000775, 122070000776, 122070000777, 120440001019, 120440001013, 122350000281, 122440001772, 122440001773, 122500001549, 122500001550, 123100001477, 123160001934, 123160001935, 123230001128, 123100001477, 123160001934, 123160001935, 123200001637, 123230001128, 124160002135, 124160002136, 124170000872, 124180000269, 124220001303, 124220001304; 37) UDI/DI 00732094260533, Serial Numbers: 117390588115, 117390588116, 117390588117, 117390588118, 111130075526; 38) UDI/DI 00732094260557, Serial Numbers: 114150206492, 114450235208, 117390588112, 117390588113, 117390588114, 118480000835, 119350003345, 121280001920, 121280001921, 122070001253, 122070001254, 122130000799, 122260000202, 122260000203, 122260000204, 122260000205, 122260000206, 122260000207, 122260000208, 123070001809, 123090001127, 123110000416, 123200001005, 123450001334, 123450001335, 114150206492, 123090001127, 123110000416, 123450001334, 123450001335, 124110001068, 124110001069, 124160000521; 39) UDI/DI 00732094260601, Serial Numbers: 113480185300; 40) UDI/DI 00732094260670, Serial Numbers: 118100617600, 113100154916, 118130624595, 118330000155, 118330000156, 118480000834, 119180000558, 119250001418, 119260000959, 120080000601, 120460002490, 121130001169, 121130001170, 122070001249, 122070001250, 122070001251, 122070001252, 122290000263, 122290000264, 122290000265, 122340000461, 122340000462; 41) UDI/DI 00732094260731, Serial Numbers: 116120368670; 42) UDI/DI 00732094260816, Serial Numbers: 113240166924, 117080554664, 117080554665, 117220571840, 118280000973, 118480000833; 43) UDI/DI 00732094260847, Serial Numbers: 117520603150; 44) UDI/DI 00732094260885, Serial Numbers: 116340523128, 116350524044. 117370586263; 45) UDI/DI 00732094260892, Serial Numbers: 117380586444; 46) UDI/DI 00732094260960, Serial Numbers: 117470596307, 118050609226; 47) UDI/DI 00732094260991, Serial Numbers: 116500543942, 116500543943, 116500543944, 116500543945, 116500543946; 48) UDI/DI 00732094261004, Serial Numbers: 116390529064; 49) UDI/DI 00732094261028, Serial Numbers: 116460538216, 116460538217, 116110348790, 116070311448, 117370586263, 116070311445, 116070311446, 116070311447, 119380001488; 50) UDI/DI 00732094261042, Serial Numbers: K16C001871, K16C001464, 118140625485, 118140625484, 118130623667, 118120623366, 118120623365, 118120623364, 118120623363, 118120623362, 118120623360, 118120623359, 118120623356, 118120623355, 118120623358, 118120623361, 118120623357, 118110619537, 118110619536, 118140625486, 118140625488, 118140625489, 118140625490, 118140625491, 118140625492, 118140625493, 119050000696, 119350003340, 119470002302, 119490000509, 21119350003340, 21119490000509, 119520000628, 120010000572, 120050001447, 21120010000572, 21120050001447, 121010000496, 118120623358; 51) UDI/DI 00732094261196, Serial Numbers: 118270000496, 118270000497, 118270000498, 118310000442, 118310000443, 118310000444, 118310000445, 118310000446, 118310000447, 118460002316; 52) UDI/DI 00732094294255, Serial Numbers: 118280001663, 118280001664, 118450000678, 118450000679, 118280001663; 53) UDI/DI 00732094294538, Serial Numbers: 120140002538, 120140002539, 120320001826, 120320001827, 121060001018, 122220000671; 54) UDI/DI 00732094294545, Serial Numbers: 122170001364; 55) UDI/DI 00732094295429, Serial Numbers: 118360000421, 118370002214; 56) UDI/DI 00732094296303, Serial Numbers: 119420001730, 119420001731, 119420001732, 119420001733, 119420001734, 119420001735, 119420001736, 121510000646, 121510000647, 121500000303, 123180000483, 123180000484; 57) UDI/DI 00732094299908, Serial Numbers: 11810623357; 58) UDI/DI 00732094299915, Serial Numbers: 118120623355, 118120623356, 118120623365, 118120623359, 118120623363; 59) UDI/DI 00732094301472, Serial Numbers: 117500600621, 120440000589, 120440000590, 120440000591, 120440000592, 120440000593, 122440001762, 21120440000592, 12244001762, 122470000639; 60) UDI/DI 00732094302974, Serial Numbers: 119020000643, 121320001539, 121320001540, 121320001541, 12341, 12342, 12343, 121420001245, 121420001246, 121420001247, 121420001248; 61) UDI/DI 00732094316926, Serial Numbers: 119140001089, 119460000150, 119460000151; 62) UDI/DI 00732094320176, Serial Numbers: 122360001053, ....; 63) UDI/DI 00732094320183, Serial Numbers: 120110001003, 121050001860; 64) UDI/DI 00732094332780, Serial Numbers: 117470596305, 120070001961, 120070001962, 120070001963, 120070001964, 120070001965, 120070001966, 120070001967, 120070001968, 120070001969, 120070001970, 120070001971, 120070001972, 120070001973, 120070001974, 120070001975, 120070001976, 120070001977, 120070001978, 120070001979, 120070001980, 120070001965, 120070001970, 120070001978; 65) UDI/DI 00732094337518, Serial Numbers: 115350269606, 120270000572, 121470000326; 66) UDI/DI 00732094338805, Serial Numbers: 114340225721; 67) UDI/DI 00732094339444, Serial Numbers: 120400001336; 68) UDI/DI 00812345027556, Serial Numbers: 116130382889, 116250489751, 116490541979, 117260576365, 118260000798, 118260000799, 117270577497, 117270577498, 118400001533, 118460001735, 119100000089, 119100000090, 120450001963, 120530000477, 121140001840, 121250000689, 121380000301, 121400001503, 121500001615, 121500001616, 122020001911, 122020001912, 122100000411, 122130000801, 122130000802, 122130000803, 122370001278, 122390000503, 122390000504, 122390000505, 122480002479, 122510000876, 123080000426, 123080000427, 123170000296, 123520001479, 123520001480, 124030000954, 123520001474, 121380000301, 124030000954, 124170000105, 124190001474; 69) UDI/DI 00817655021997, Serial Numbers: 117370585639
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 95559This product is part of a recall event; the main page for the event is Hillrom Welch Allyn Vision Express Holter Analysis System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hillrom Welch Allyn Vision Express Holter Analysis System recalled | Baxter Healthcare | Other | IL | |
| CLASS II | Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System recalled | Baxter Healthcare | Other | IL | |
| CLASS II | Hillrom Welch Allyn Diagnostic Cardiology Suite recalled | Baxter Healthcare | Other | IL | |
| CLASS II | Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System recalled | Baxter Healthcare | Other | IL | |
| CLASS II | Hillrom Welch Allyn HScribe Holter System recalled by Baxter Healthcare | Baxter Healthcare | Other | IL |
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