Recall Z-0414-2013 ยท FSP Loupe, Diagnostic/Surgical
Kerr Corporation
The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. Th
| Date | Nov 21, 2012 (initiated Apr 10, 2012) |
| Status | Terminated |
| Reason | The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to specification, but the marking may not permanently adhere to the device. |
| Root cause | Finished device change control |
| Action | Customers were notified via USPS 1st class mail on April 10, 2012 to US and Canadian, and Rest of World (ROW) consignees, and on April 27, 2012 to European consignees. The notification letter identifies the product, reason for recall, and instructions to customers:"Please review the table below to verify that the laser loupes being used in your office has the correct filter color. ORASCOPTIC KINDLY REQUESTS YOUR COOPERATION IN COMPLETING AND FAXING BACK THE ENClOSED ACKNOWLEDGEMENT FORM IN ORDER TO CONFIRM YOUR RECEIPT OF THIS FIELD CORRECTION. If you are an authorized Orascoptic distributor, |
| Quantity | 639 units |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Canada and EU. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.