Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Reported: September 18, 2013 Initiated: August 19, 2013 #Z-2191-2013
Product Description
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
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.
Details
- Recalling Firm
- Lumenis, Inc.
- Units Affected
- 3 units
- Distribution
- Distributed in the states of NJ, PA, and IL.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.. Recalled by Lumenis, Inc.. Units affected: 3 units.
Why was this product recalled? ▼
Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2013. Severity: Moderate. Recall number: Z-2191-2013.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11