Surgical laser consoles recalled over a label missing the DANGER symbol
Leaseir Technologies is recalling two MHR Xcell surgical laser systems because the console label on the affected devices is missing the "DANGER" symbol.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 under the documentation criterion: the record cites a missing symbol on a console label, with no device defect or stated consequence.
Plain-English summary
The LEASEIR MHR XCELL, model/catalog number MHR 110-b, software version 1.5.0.0, is being recalled by Leaseir Technologies SLU. The record describes the Leaseir MHR Xcell as a surgical laser instrument for use in general and plastic surgery and dermatology.
The reason given in the enforcement record is that the console label for affected devices is missing the "DANGER" symbol.
The record lists 2 units, serial numbers C10016 and C10017, UDI-DI 08437019546076. The distribution field reads 'US Nationwide distribution in the states of Austin, Texas', naming a city where a state is expected; it is reported here as printed. The FDA has classified the action as Class II.
The record cites a missing label symbol rather than a device defect, and reports no injuries. Facilities should follow Leaseir's instructions.
The recalled product
- Product
- 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 treatm
- Manufacturer
- LEASEIR TECHNOLOGIES SLU
- Category
- Medical Device — Surgical laser
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code: Device#1: Model: Leaseir MHR Xcell Serial Number: C10016
- C10017 UDI-DI: 08437019546076
Distribution
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