Leica Microsystems, Inc.: Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737

Recall number

Z-1850-2022

Recalling firm

Leica Microsystems, Inc.

Product

Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737

Status

Open, Classified

Initiated

2022-08-26

Posted

2022-09-29

Terminated

not on file

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.

Root cause

Component change control

Action

The firm sent a Field Safety Notice to its consignees on 08/26/2022 by mail. The notice described the problem and stated that A Leica Microsystems representative will be contacting the consignee's to arrange this no-cost field update of the instrument. The field update will be scheduled to occur at your convenience within the next 6 months. The notice provided the following workaround: "Advice on action to be taken by the user: " You can continue to use the system pending this field update. Based on our analysis the probability is very remote that an unacceptable patient risk will occur due to the incorrect BrightCare Plus functionality caused by the non-conforming photodiode. " However, please ensure that all users of the affected microscope are aware of the Dangers of Use as described in section 3.4 and will follow the directions in section 5.3 ( Illumination ) and section 8 ( Operation ) of the user manual when handling a surgical operating microscope see excerpts below: o 3.4 Dangers of Use : &do not set the light intensity too high. & because if &light intensity is too high, uncontrolled tissue heating may occur. o 5.3 Illumination : &begin with a low light intensity and increase it until an optimum level of illumination is achieved. o 8 Operation : &use the lowest comfortable light intensity. The notice also requested acknowledgement of receipt of the Field Safety Notice as follows: "Please acknowledge receipt of this Field Safety Notice with the digital acknowledgment form by either scanning the QR code in your mobile phone or with the following link: https://forms.office.com/r/1WPXW93ugL."

Quantity

115 devices

Distribution

US Nationwide distribution.

Lot, serial or model codes

Serial Numbers: 270422001, 160322001, 230222001, 140422001, 100122002, 60721001, 290522001, 310522001, 81121001, 290921001, 130122001, 111021001, 131021001, 171021001, 10622002, 280222002, 51121001, 90821001, 170222001, 170522001, 11221001, 310322001, 260522001, 270522001, 140222001, 270422002, 30122001, 70122001, 271121001, 300322001, 31221001, 41221001, 230222002, 221121001, 70422001, 60122001, 120522001, 90921001, 200122001, 140122001, 100122001, 100721001, 100721002, 110721001, 20522001, 30921001, 261021001, 210422001, 40422001, 240122001, 140721001, 30821001, 50821001, 280721001, 290721001, 300721001, 300821001, 161021001, 160921002, 110222001, 91121001, 141221001, 151221001, 111221001, 301221001, 120222001, 120721001, 160122001, 291221001, 200721001, 91221001, 20921001, 220621001, 131121001, 161121001, 80422001, 240522001, 190821001, 300921001, 61021001, 80721001, 160921001, 10921001, 270122001, 90122001, 10622001, 50122001, 80422002, 211021001, 251021001, 200522001, 110522001, 130522001, 140522001, 110821002, 60522001, 200821001, 210921001, 20322002, 70322001, 100322002, 190322001, 30322001, 301021001, 30522001, 50721001, 261221001, 111121001, 81121002, 261121001, 301121001, 130821001, 60422002, 11221001, 140222002

510(k) numbers

not on file

PMA numbers

not on file

Product code

FSO

Firm FEI

3000210133

Firm city

deerfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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