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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90818

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 26, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Leica Microsystems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063

Z-1848-2022
Recall number
Z-1848-2022
Initiated
August 26, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Leica Microsystems, Inc.
Quantity
30 devices

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: 30622001, 41221001, 100522001, 50322001, 60522001, 11221001, 301121001, 20622001, 191121001, 91221001, 61221001, 81221001, 281121001, 291121001, 181121001, 300522001, 71221001, 20322001, 30322001, 60322001, 61221002, 21221001, 241121001, 101221001, 251121001, 31221001, 261121001, 91221002, 101221002, 51221001,

Distribution pattern

US Nationwide distribution.

device · product 2 of 4

Leica Surgical Operating Microscopes, Arveo, Part Number 10448999

Z-1849-2022
Recall number
Z-1849-2022
Initiated
August 26, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Leica Microsystems, Inc.
Quantity
25 devices

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: 210721001, 180721001, 190721001, 121021001, 100821001, 60821001, 90821001, 120821001, 10821001, 80721001, 40821001, 130821001, 290821001, 240821001, 91021001, 180921001, 181121001, 151021001, 190821001, 160921001, 20721001, 50721001, 40921001, 150821001, 160821001

Distribution pattern

US Nationwide distribution.

device · product 3 of 4

Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737

Z-1850-2022
Recall number
Z-1850-2022
Initiated
August 26, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Leica Microsystems, Inc.
Quantity
115 devices

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide distribution.

device · product 4 of 4

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

Z-1851-2022
Recall number
Z-1851-2022
Initiated
August 26, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Leica Microsystems, Inc.
Quantity
32 devices

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

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.

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.