CLASS II ONGOING Device recall · Reported 10 Jun 2026 · FDA Enforcement Report
MAC 5 A4 Resting ECG Analysis System recalled
GE Medical Systems China is recalling MAC 5 A4 Resting ECG Analysis System 855001-001, distributed nationwide in the US. The recall was initiated on 21 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2306-2026
- FDA event ID
- 98917
- Recalling firm
- GE Medical Systems China, Wuxi
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Apr 2026
- FDA classified
- 3 Jun 2026
- Reported
- 10 Jun 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 21 Apr 2026 | Recall initiated by company | |
| 3 Jun 2026 | Classified by FDA | +43 days |
| 10 Jun 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Where it was distributed
Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124
Where was it sold?
Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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