FDA Medical Device Recalls (openFDA)
Lumenis Inc.: 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
- Recall number
- Z-0529-06
- Recalling firm
- Lumenis Inc.
- 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
- Status
- Terminated
- Initiated
- 2005-04-08
- Posted
- 2006-02-16
- Terminated
- 2006-12-28
- Reason
- Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.
- 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
- 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.
- Lot, serial or model codes
- Software versions lower than 2.02 All serial numbers; All codes
- 510(k) numbers
- ["K030342"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 2914019
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28