Recall Z-0301-2017 ยท GEX Powered Laser Surgical Instrument
Lumenis Limited
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
| Date | Oct 23, 2016 (initiated Sep 25, 2016) |
| Status | Terminated |
| Reason | The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On 9/25/16 consignees were notified via an Urgent - Field Safety Corrective Action letter with a FemTouch disassembly tool kit as well as FemTouch disassembly instructions. The instructions describe the simple disassembly process to be performed as part of the Pre-cleaning phase and the process for reassembling the device prior to re-use. It is recommended that customers clean and sterilize all of their handpieces according to the pre-cleaning disassembly process before each use. Consignees were asked to complete and return a verification form. Questions about the FSCA, should be directed |
| Quantity | 69 units |
| Distribution | Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100415 | ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM Lumenis, Apr 21, 2010 |