FDA Medical Device Recalls (openFDA)
GE Medical Systems China Co., Ltd.: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
- Recall number
- Z-2306-2026
- Recalling firm
- GE Medical Systems China Co., Ltd.
- Product
- MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
- Status
- Open, Classified
- Initiated
- 2026-04-21
- Posted
- 2026-06-03
- Terminated
- not on file
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- 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.
- Quantity
- 16
- Distribution
- Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
- Lot, serial or model codes
- Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124
- 510(k) numbers
- ["K221321"]
- PMA numbers
- not on file
- Product code
- DXH
- Firm FEI
- 3003513129
- Firm city
- Wuxi
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28