MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
FDA device recall Z-2306-2026 · posted 2026-06-03 · Open, Classified
Recall details
- Recalling firm
- GE Medical Systems China Co., Ltd.
- 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.
- Action taken
- Firm notified consignees beginning April 21, 2026 via letters titled "URGENT MEDICAL DEVICE CORRECTION". Customers were given instructions on how to check their software version. If a customer's software version begins with 3.00, the customer should not use the system until a GE HealthCare representative has updated the device with the latest licensed software version.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Open, Classified
- Product code
- DXH
- Quantity affected
- 16
- Distribution
- Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
- Date initiated
- 2026-04-21
- Date posted
- 2026-06-03
- Location
- Wuxi, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System (K221321) | Ge Medical Systems Information Technologies, Inc. | 2022-10-18 |