[pending] Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Vers
Pending LLM rewrite. Source: FDA_DEVICE Z-1130-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The console label for affected devices is missing the "DANGER" symbol.
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 — Devices
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
Distributed nationwide across the United States.
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