Cardiac Workstation 7000 — Class II medical device recall Z-2956-2026
Ongoing recall by Philips North America Llc, reported 2026-08-26, distributed nationwide. Device will intermittently provide inaccurate data related to native heart rate.
| Recall number | Z-2956-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2026-07-01 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CA, CH, CZ, DE, DO, ES, FR, GB, HK, HR, IE, IQ, IS, IT, KR, LU, MT, NL, NO, NZ, PL, PT, QA, RS, SA, SE, SG, SI, SK, TH, TW |
| Quantity | 1,810 units |
| UPC / GTIN / UDI-DI | 00884838094833 |
| Serial numbers | CN12520174, CN12621557, CN12621562, CN12621576, CN12621577, CN12621579, CN12621580, CN12621687, CN12621690, CN12621696, CN12621697, CN12621698, CN22520206, CN22520214, CN22520215, CN22520218, CN22520226, CN22520242, CN22621734, CN22621798, CN22621799, CN22621874, CN32520246, CN32621875, CN32621877 and 323 more |
Product
Cardiac Workstation 7000. Product Number: 860441.
Reason for recall
Device will intermittently provide inaccurate data related to native heart rate.
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-2956-2026. 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.