Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the trea
FDA device recall Z-2733-2014 · posted 2014-09-30 · Terminated
Recall details
- Recalling firm
- Lumenis, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 16
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.
- Date initiated
- 2014-08-15
- Date posted
- 2014-09-30
- Date terminated
- 2014-10-21
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCANNING LASERLINK (K130195) | Lumenis, Inc. | 2013-11-01 |