Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial Park, Yokneam, Israel 20692
FDA Recall Z-0529-06 · Posted 2006-02-16
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Recalling FirmLumenis Inc.
Recall StatusTerminated
Product CodeGEX
Date Initiated2005-04-08
Date Terminated2006-12-28
Product Quantity142 units
Reason for Recall
Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.
Firm Action
On 4/8/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
Root Cause
Other
Distribution Pattern
The product was released for distribution to 124 consignees nationwide. One international consignee includes: New Zealand. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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