FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional tre
FDA device recall Z-0301-2017 · posted 2016-10-23 · Terminated
Recall details
- Recalling firm
- Lumenis Limited
- Reason for recall
- 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.
- Action taken
- 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 to the Lumenis field correction administrator, Rafi Barel at Rafi.Barel@lumenis.com.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 69 units
- Distribution
- Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
- Date initiated
- 2016-09-25
- Date posted
- 2016-10-23
- Date terminated
- 2017-04-11
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM (K100415) | Lumenis | 2010-04-21 |