FDA Device recall Z-0165-2026
Cardiac Workstation 5000
- FDA Device
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of Cardiac Workstation 5000 by Philips North America, citing failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0165-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-12 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Cardiac Workstation 5000; Model Number: 860439;
Reason
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Identifiers
| code_info | Model Number: 860439; UDI-DI: 00884838094826; Serial Numbers: |
|---|
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-0165-2026%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.