Reported Oct 5, 2022 · Ongoing
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
Leica Microsystems, Inc.
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: Leica Microsystems, Inc. · 10 Parkway North blvd ste 300 · deerfield, IL · 60089-6622
Is this the product you have?
- Leica Surgical Operating Microscopes
- PROvido Part Numbers
a. 10448976b. 10448950
- Lot codes and dates
- a. 10448976
- Serial Numbers
120322001300122001170921001301221001401220011405220011512210023010210028122100210022200240222002220821001300122002110322001503220011809210012608210019062200112042200110052200190522001210821001250122001301021001100222001b. 10448950
- Serial Numbers
1602220019072100150422001504220029122100116092100161221001
- Amount recalled
- 32 devices
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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