Z-0529-06

Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by...

Name: Z-0529-06 Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by...
Creator: Lumenis Inc.
Published: 2005-04-08
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2005-04-08 / Terminated / root cause: software

FDA source

Lumenis Inc. began a recall of Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial... on 2005-04-08. The reason FDA records is "Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns". 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-0529-06
Status: Terminated
Initiated: 2005-04-08
Posted: 2006-02-16
Terminated: 2006-12-28
Recalling firm: Lumenis Ltd
Product: 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
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.
Root cause tag: software
FDA root cause: Other
Action: On 4/8/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
Quantity in commerce: 142 units
Distribution: 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.
Product codes and lots: Software versions lower than 2.02 All serial numbers; All codes

Product code GEX

K030342Class IILumenis Family of Ipl Systems and Combination Ipl/nd:yag SystemsLumenis, Ltd. / cleared 2003-07-17

MDM coverage of this record lists here, newest first.

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)