Device product
Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.
Z-2080-2012
Product summary
- Event
- Event 62432
- Status
- Terminated
- Classification
- Class II
- Quantity
- 86,000 units
- Official record key
device-enforcement:Z-2080-2012
Official wording
Reason: Imaging artifact can occur on mammogram result
Code information: Lot Numbers: 107657, 108150, 108833
Distribution pattern: International Distribution including Nationwide(USA), and the countries of Japan and Canada.
Derived failure modes
-
Unknown
Imaging artifact can occur on mammogram result