Z-1851-2022Class II

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

Name: Z-1851-2022 Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
Creator: Leica Microsystems, Inc.
Published: 2022-08-26
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2022-08-26 / Open, Classified / root cause: software

FDA source

Leica Microsystems, Inc. began a recall of Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950 on 2022-08-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1851-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-26
Posted: 2022-09-29
Recalling firm: Leica Microsystems, Inc.
Product: Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
Product code: FSO Microscope, Surgical, General & Plastic Surgery
Reason for recall: 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 tag: software
FDA 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 in commerce: 32 devices
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1851-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1848-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-29
Z-1849-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-29
Z-1850-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-29
Z-1851-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-29

Product code FSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)