Z-2306-2026 Class II Ongoing
FDA device recall Z-2306-2026 was initiated by GE Medical Systems China Co., Ltd. on April 21, 2026 and is designated Class II. 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 cl… The recall status is ongoing. Affected quantity: 16.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2026
- Initiation Date
- April 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
Code Information
Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124