Recall record at a glance
| Official record | Z-1519-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Lumenis Limited |
| Report date | May 6, 2015 |
| Recall initiation date | Mar 25, 2015 |
| Quantity | 117 units |
| Location | Yokneam, Israel |
Official product description
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
Why the product was recalled
Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation.
Distribution information
Worldwide distribution. US nationwide (to OR, NM, NY, IL, and CO), Switzerland, Canada, Italy, Great Britain, United Arab Emirates, France, Belgium, India, Israel, Japan, Portugal, Czech Republic, Kuwait, Germany, Spain, Georgia, Armenia, Slovenia, New Zealand, Saudi Arabia, and Russian Federation.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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