Recall Z-0320-2025 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Baxter Healthcare Corporation
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
| Date | Nov 7, 2024 (initiated Oct 11, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 599 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K004017 | H-SCRIBE Mortara Instrument, Inc., Jun 11, 2001 |