The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***S
FDA device recall Z-0005-2014 · posted 2013-10-01 · Terminated
Recall details
- Recalling firm
- PhotoMedex, Inc.
- Reason for recall
- Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 549
- Distribution
- Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.
- Date initiated
- 2013-01-04
- Date posted
- 2013-10-01
- Date terminated
- 2014-04-16
- Location
- Montgomeryville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS (K082721) | Photo Medex, Inc. | 2008-10-28 |