Cardiac Workstation 7000 — Class II medical device recall Z-0166-2026
Ongoing recall by Philips North America, reported 2025-10-22, distributed nationwide. Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Wor
| Recall number | Z-0166-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2025-09-12 |
| Classified | 2025-10-16 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 29 units |
| UPC / GTIN / UDI-DI | 00884838094833 |
| Serial numbers | US22520221, US22520238, US32520244, US32520248, US42520284 |
| Model numbers | 860441 |
Product
Cardiac Workstation 7000; Model Number: 860441;
Reason for recall
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0166-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.