MAC 5 A4 Resting ECG Analysis System 855001-001: recall status
Notice names this product. GE Medical Systems China Co’s MAC 5 A4 Resting ECG Analysis System 855001-001 is named in FDA Class II recall Z-2306-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: 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. Identifying details: Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124. Units affected: 16. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
MAC 5 A4 Resting ECG Analysis System 855001-001
Company / brand
GE Medical Systems China Co
Lot / serial / date codes
Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124
Distribution
Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
Agency product description and boundaries
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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. …