Recall Z-2306-2026 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
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
| Date | Jun 3, 2026 (initiated Apr 21, 2026) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System Ge Medical Systems Information Technologies, Inc., Oct 18, 2022 |