FDA Medical Device Recalls (openFDA)
Lumenis Limited: FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
- Recall number
- Z-0301-2017
- Recalling firm
- Lumenis Limited
- Product
- FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
- Status
- Terminated
- Initiated
- 2016-09-25
- Posted
- 2016-10-23
- Terminated
- 2017-04-11
- 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 to the Lumenis field correction administrator, Rafi Barel at Rafi.Barel@lumenis.com.
- Quantity
- 69 units
- Distribution
- Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K100415"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3004135191
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28