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Recall Observatory FDA recall evidence

Device product

Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950

Z-1851-2022

August 26, 2022

Class II

Product summary

Firm
Leica Microsystems, Inc.
Event
Event 90818
Status
Ongoing
Classification
Class II
Quantity
32 devices
Official record key
device-enforcement:Z-1851-2022

Official wording

Reason: 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.

Code information: a. 10448976, Serial Numbers: 120322001, 300122001, 170921001, 301221001, 40122001, 140522001, 151221002, 301021002, 81221002, 100222002, 40222002, 220821001, 300122002, 110322001, 50322001, 180921001, 260821001, 90622001, 120422001, 100522001, 90522001, 210821001, 250122001, 301021001, 100222001; b. 10448950, Serial Numbers: 160222001, 90721001, 50422001, 50422002, 91221001, 160921001, 61221001

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.