Recall Z-0005-2014 ยท GEX Powered Laser Surgical Instrument
PhotoMedex, Inc.
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH
| Date | Oct 1, 2013 (initiated Jan 4, 2013) |
| Status | Terminated |
| Reason | Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier. |
| Root cause | Process change control |
| Action | The firm initiated their recall of these products beginning on January 4, 2013 by sending notification letters to their consignees via electronic mail and/or facsimile. Customers were asked to return the affected product for a replacement. |
| Quantity | 549 |
| Distribution | Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082721 | LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS Photo Medex, Inc., Oct 28, 2008 |