Z-2080-2012 Class II Terminated
FDA device recall Z-2080-2012 was initiated by Beekley Corporation on July 2, 2012 and is designated Class II. Reason for recall: Imaging artifact can occur on mammogram result The recall status is terminated (terminated July 9, 2013). Affected quantity: 86,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2012
- Initiation Date
- July 2, 2012
- Termination Date
- July 9, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 86,000 units
Product Description
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.
Reason for Recall
Imaging artifact can occur on mammogram result
Distribution Pattern
International Distribution including Nationwide(USA), and the countries of Japan and Canada.
Code Information
Lot Numbers: 107657, 108150, 108833