FDA Device recall Z-2306-2026
MAC 5 A4 Resting ECG Analysis System 855001-001
- FDA Device
- Class II
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class II recall of MAC 5 A4 Resting ECG Analysis System 855001-001 by Ge Medical Systems China, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2306-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-21 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Ge Medical Systems China |
| Distribution | US |
Product
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Reason
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.
Identifiers
| code_info | Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Device · Class I · 2025-12-24 · Ge Medical Systems China - GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222
FDA Device · Class I · 2025-12-24 · Ge Medical Systems China - GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
FDA Device · Class II · 2025-07-02 · Ge Medical Systems China - GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog…
FDA Device · Class II · 2025-07-02 · Ge Medical Systems China
All Ge Medical Systems China recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2306-2026%22
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