Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pa
FDA device recall Z-2191-2013 · posted 2013-09-11 · Terminated
Recall details
- Recalling firm
- Lumenis, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 3 units
- Distribution
- Distributed in the states of NJ, PA, and IL.
- Date initiated
- 2013-08-19
- Date posted
- 2013-09-11
- Date terminated
- 2013-12-19
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISION ONE LASER SYSTEM (K111213) | Lumenis, Inc. | 2011-07-25 |