Recall Z-0320-2025
Baxter Healthcare Corporation · initiated October 11, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Codes / lots: Software Versions: Software Version V4.0.0 V4.34, release date 26-Oct-2005; Software Version V6.1.0 V6.4.1, release date 02-Aug-2016 Units: 1) UDI/DI 00732094263992, Serial Numbers: 119470002280; 2) UDI/DI 00732094264043, Serial Numbers: 112320127784, 113500186660, 114300222272, 115350270164, 116490541266, 117360584925, 117440592623, 117440592624, 117440592625, 117510602023, 118330000138, 118180634304, 118480000469; 3) UDI/DI 00732094264074, Serial Numbers: 113240166856, 114070193758, 118060610823, 118130624139, 118130624138, 118110619525, 118110619527, 118110619528, 118110619526, 118200638074, 120070000189, 120070000190, 120070000191, 120070000192, 120070000193, 21120070000193, 120420002116, 120420002117, 120420002118, 120420002119, 120420002120, 120460000676, 120460000677, 120460000678, 120460000679, 120460000680, 122090001190, 122200001820; 4) UDI/DI 00732094264111, Serial Numbers: 117490600194; 5) UDI/DI 00732094296297, Serial Numbers: 118390000385, UNKNOWN1, 118390000386, 119420001709, 119420001710, 119420001711, 119420001712, 119420001713, 119420001714, 119420001715; 6) UDI/DI 00817655020112, Serial Numbers: 115500283784, 116400529497, 116400530902, 116510545319…
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.
FDA-determined cause: Software design
Action taken
Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 10/11/2024 via USPS First Class Mail. The notice explained the issue, potential hazard to the patient, and provided instructions for the to the system IT administrator to correct the issue which is already available in the current version of software.
Details
- Recall number
- Z-0320-2025
- Initiated
- October 11, 2024
- Posted by FDA
- November 7, 2024
- Product code
- MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm
- Quantity
- 599 units
- Distribution
- Worldwide distribution.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0321-2025 Class II | Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress testThere is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system… | 10/11/2024Open, Classified |
| Z-0322-2025 Class II | Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; ElectrocardiographThere is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system… | 10/11/2024Open, Classified |
| Z-0323-2025 Class II | Hillrom Welch Allyn Vision Express Holter Analysis System; ElectrocardiographThere is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system… | 10/11/2024Open, Classified |
| Z-0324-2025 Class II | Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic…There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system… | 10/11/2024Open, Classified |
| Z-0325-2025 Class II | Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic…There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system… | 10/11/2024Open, Classified |