Z-1951-2019 Class II Ongoing
FDA device recall Z-1951-2019 was initiated by GE Healthcare, LLC on January 19, 2019 and is designated Class II. Reason for recall: Additional low dose radiation exposure. The recall status is ongoing. Affected quantity: 857 (US = 195: OUS = 662).
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2019
- Initiation Date
- January 19, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 857 (US = 195: OUS = 662)
Product Description
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Reason for Recall
Additional low dose radiation exposure.
Distribution Pattern
Worldwide - US Nationwide Distribution
Code Information
Revolution CT