Z-2733-2014Class II

Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use...

Name: Z-2733-2014 Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use...
Creator: Lumenis, Inc.
Published: 2014-08-15
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2014-08-15 / Terminated / root cause: software

FDA source

Lumenis, Inc. began a recall of Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the... on 2014-08-15. FDA classified it as Class II and gives the reason as "Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern". 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-2733-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-15
Posted: 2014-09-30
Terminated: 2014-10-21
Recalling firm: Lumenis Ltd
Product: Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: " Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy " Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy " Choroidal Neovascularization " Retinal Neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) " Macular Edema associated with Branch Retinal Vein Occlusion " Retinal Tears and Detachments And Anterior Segments as follows: " Iridotomy in Closed Angle Glaucoma " Trabeculoplasty in Open Angle Glaucoma
Product code: HQF Laser, Ophthalmic
Reason for recall: Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern.
Root cause tag: software
FDA root cause: Software design
Action: Lumenis sent a Safety Advisory Notice dated July 15, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed that Lumenis would contact consignees to schedule a product update, to be completed at a convenient time. For questions consignees should call 801-656-2549. For questions regarding this recall call 801-656-2690.
Quantity in commerce: 16
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.
Product codes and lots: All assembled units since product release, Part Number: GA-0006700.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2733-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2733-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30

Product code HQF

K130195Class IIScanning LaserlinkLumenis, Inc. / cleared 2013-11-01

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)