United StatesLeaseir Technologies’ LEASEIR MHR XCELL surgical laser instrument (Model MHR 110-b, Software Version 1.5.0.0; serial numbers C10016 and C10017, UDI-DI 08437019546076) used for hair removal and treatment of pseudofolliculitis barbae is affected. It was recalled because the console label for the two affected devices is missing the "DANGER" symbol; the units were distributed in Austin, Texas.
What's being recalled
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled…
Recalling firm: Leaseir Technologies Slu, Gijon, Spain.
How to identify it
Lot Code: Device#1: Model: Leaseir MHR Xcell Serial Number: C10016, C10017 UDI-DI: 08437019546076
The hazard
The console label for affected devices is missing the "DANGER" symbol.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of Austin, Texas.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)