Z-0301-2017Class II

FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide...

Name: Z-0301-2017 FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide...
Creator: Lumenis Limited
Published: 2016-09-25
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2016-09-25 / Terminated / root cause: software

FDA source

Lumenis Limited began a recall of FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology on 2016-09-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0301-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-25
Posted: 2016-10-23
Terminated: 2017-04-11
Recalling firm: Lumenis Ltd
Product: FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: software
FDA 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 [email protected].
Quantity in commerce: 69 units
Distribution: Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0301-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0301-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-23

Product code GEX

K100415Class IIAcupulse 30/40 St CO2 Laser System and Acupulse 40Wg CO2 Laser SystemLumenis / cleared 2010-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)