Recall Z-2080-2012 ยท IZH System, X-Ray, Mammographic
Beekley Corporation
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.
| Date | Jul 2, 2012 |
| Status | Terminated |
| Reason | Imaging artifact can occur on mammogram result |
| Root cause | Nonconforming Material/Component |
| Action | Beekley Medical issued "Urgent: Medical Device Recall" notifications dated June 29, 2012 that were sent via certified mail USPS on July 2, 2012. The product issue was was described and customers were provided the recommended actions. Customer Service number is 1-800-233-5539. |
| Quantity | 86,000 units |
| Distribution | International Distribution including Nationwide(USA), and the countries of Japan and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073262 | BELLA Beekley Corp., Mar 26, 2008 |