Leica recalls M220 F12 Surgical Microscope systems due to potential risk of optics carrier dropping into surgical field. Affected units have specific serial numbers; contact Leica for details.
In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.
Leica is recalling its M220 F12 Surgical Microscope systems after one complaint reported a defect where the optics carrier might unintentionally drop into the surgical field. This could risk contact with patients during use.
The defect could cause the microscope's optics carrier to drop into the surgical field without warning. This poses a risk of accidental patient contact during procedures, though no injuries have been reported.
Surgical staff and hospitals using the Leica M220 F12 Microscope systems are most at risk. The recall affects specific units with listed serial numbers.
Check for serial numbers listed in the recall notice: U.S. serial numbers start with 180709002 and similar patterns, and Canada serial numbers follow a different format. The product is a surgical microscope system.
Compare your serial number to the list of affected U.S. and Canada serial numbers provided in the recall notice.
The recall states there was one complaint but no patient injuries were reported. However, the defect could cause the optics carrier to drop into the surgical field, risking patient contact.
Check your serial number against the list of affected U.S. and Canada serial numbers provided in the recall notice.
The recall does not specify a remedy, so contact Leica directly for guidance on next steps.
We’ve drafted a message you can send Leica to request your refund or repair — edit it as you like.
Subject: Recall Z-0412-2022 — Leica Leica Hello, I own a Leica that is covered by recall Z-0412-2022 from Leica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
