Reported May 6, 2015 · Terminated
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
Lumenis Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lumenis Limited · 13 Hayetzira St.,Yokneam Ind. Park · Yokneam · N/A
Is this the product you have?
- Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
- Lot codes and dates
- Lot numbers
128 of 128 codes
XI0017XI0018XI0023XIP0043182184185XIP0049236237239240242248249250251254256257XIP0038XIP0131XIP01253048305230653074XI0012XIP0143XIP0144XI0001XIP0072XI0028XIP0061XI0028XI0036XIP0074XIP0077XIP0082XIP0087XIP0132XIP0127XIP0124XIP0129XI0008XI0029XI0037XI0046XIP0123XIP0059XIP0107XIP0089XIP0096XIP0156XI0005XIP0114XI0014XI0022XI0015XI0021
- Lot numbers
- Amount recalled
- 117 units
Where it was sold
Why it 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.
This product could cause temporary or reversible health problems — stop using it.
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