FDA Device recall Z-0320-2025
Hillrom Welch Allyn HScribe Holter System
- FDA Device
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of Hillrom Welch Allyn HScribe Holter System by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0320-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-11 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
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.
Identifiers
| code_info | Software Versions: Software Version V4.0.0 V4.34, release date 26-Oct-2005; Software Version V6.1.0 V6.4.1, rele…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0320-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.