- Recalling firm
- GE Medical Systems China Co., Ltd.
- 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.
- Affected products (lot / model / serial)
- Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124
- Units affected
- 16
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
- Firm location
- Wuxi, China
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2306-2026
- Recall initiated
- April 21, 2026
- FDA classification date
- June 3, 2026
- FDA report date
- June 10, 2026
- FDA event ID
- 98917
- Last updated on HTM Vibe
- July 23, 2026