MAC 5 A4 Resting ECG Analysis System 855001-001 — Class II medical device recall Z-2306-2026
Ongoing recall by GE Medical Systems China Co., Ltd., reported 2026-06-10, distributed nationwide. Software in development inadvertently made available for customer use. Use of this software version can result
| Recall number | Z-2306-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems China Co., Ltd., Wuxi, China |
| Recall initiated | 2026-04-21 |
| Classified | 2026-06-03 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, IN, IT, KR |
| Quantity | 16 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00195278276070, 00195278276124 |
Product
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Reason for recall
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.
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-2306-2026. 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.