Z-2004-2021 Class II
FDA device recall Z-2004-2021 was initiated by GE Healthcare, LLC on March 19, 2021 and is designated Class II. Reason for recall: GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x… Affected quantity: 197 (US = 40; OUS = 157).
Recall Details
- Product Type
- Devices
- Report Date
- July 14, 2021
- Initiation Date
- March 19, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 197 (US = 40; OUS = 157)
Product Description
Revolution CT
Reason for Recall
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
Distribution Pattern
Worldwide distribution - US Nationwide
Code Information
5590000 5590000-6 5590000-2