Z-2191-2013Class II

Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment...

Name: Z-2191-2013 Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment...
Creator: Lumenis, Inc.
Published: 2013-08-19
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2013-08-19 / Terminated / root cause: software

FDA source

Lumenis, Inc. began a recall of Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology on 2013-08-19. FDA classified it as Class II and gives the reason as "Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user". 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-2191-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-19
Posted: 2013-09-11
Terminated: 2013-12-19
Recalling firm: Lumenis Ltd
Product: Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
Root cause tag: software
FDA root cause: Software design
Action: Customer's were notified via letter on 8/19/13. Service visits to consignees were scheduled with anticipated completion on 8/26/13 to replace the control board. Consignee monitoring was performed by use of return reply verification tracking cards returned by the Lumenis service engineer after completion of CPU board replacement.
Quantity in commerce: 3 units
Distribution: Distributed in the states of NJ, PA, and IL.
Product codes and lots: Model: GA-0025020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2191-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2191-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11

Product code GEX

K111213Class IIVision One Laser SystemLumenis, Inc. / cleared 2011-07-25

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)