Recall Z-1787-2014 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Beekley Corporation
Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
| Date | Jun 13, 2014 (initiated Jun 19, 2013) |
| Status | Terminated |
| Reason | Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots |
| Root cause | Error in labeling |
| Action | Beekley sent an Urgent Medical Device Recall letters dated June 19, 2013 via FedEx with signature and tracking confirmation. The letter identified the affected product, problem and actions to be taken. Firm requests users to examine inventory, remove and return recalled product. For questions contact Chelsea Fuller, Regulatory Manager at 1-800-233-5539 x 491 |
| Quantity | 81 boxes |
| Distribution | Worldwide Distribution - USA in the states of CA, FL, MA, NC, NY, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.