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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91200

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

Open FDA event record

Event summary

Timeline bucket
November 21, 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

3 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 3

Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system

Z-0475-2023
Recall number
Z-0475-2023
Initiated
November 21, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Leica Microsystems, Inc.
Quantity
43 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

Code information

Serial Numbers: 20522001, 20722001, 21221001, 40222001, 40722001, 70722001, 80522002, 110722001, 150422001, 180322001, 211021001, 260722001, 290422001, 300122001, 270522001. ***EXPANSION 09/08/2023, Serial Numbers: 271222001, 100423002, 31022001, 180623001, 71222001, 210523002, 270922002, 120623002, 100123001, 130623001, 290922002, 300922002, 210223001, 220223001, 251122001, 281122001, 20623002, 60922001, 200822001, 40523001, 40523002, 270922001, 61122002, 20423001, 300523002, 190822002, 300922001, 280922001.

Distribution pattern

US Nationwide

device · product 2 of 3

Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system

Z-0476-2023
Recall number
Z-0476-2023
Initiated
November 21, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Leica Microsystems, Inc.
Quantity
38 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

Code information

***EXPANSION 09/08/2023 UPDATE a. Premium Part Number 10448950; Serial Numbers: 160222001, 280622001, 50422001, 50422002, 91221001, 180622001, 170622001, 61221001, 130922001, 120623001, 150623001, 81022001, 200623001, 51022001, 61022001. b. Standard Part Number 10448976; Serial Numbers: 120322001, 300122001, 40222002, 301221001, 40122001, 140522001, 151221002, 81221002, 100222002, 300122002, 110322001, 50322001, 90622001, 120422001, 90522001, 100522001, 250122001, 100222001, 171022001, 80922001, 70623001, 30922001, 91022001.

Distribution pattern

US Nationwide

device · product 3 of 3

Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system

Z-0477-2023
Recall number
Z-0477-2023
Initiated
November 21, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Leica Microsystems, Inc.
Quantity
148 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

Code information

Serial Numbers: 10622001, 10622002, 10822001, 20322002, 20522001, 20622001, 30122001, 30322001, 30522001, 30622002, 30722001, 31221001, 40422001, 41221001, 50122001, 60122001, 60522001, 60622001, 70122001, 70322001, 70422001, 70622001, 80422001, 80422002, 80722001, 80822001, 90122001, 90622001, 91221001, 100122001, 100122002, 100322002, 100622001, 100622002, 110222001, 110522001, 110822001, 111221001, 120222001, 120522001, 130122001, 130522001, 130622001, 140122001, 140222001, 140422001, 140522001, 141221001, 151221001, 160122001, 160322001, 160622001, 160622002, 170222001, 170522001, 190322001, 190622001, 200122001, 200522001, 200722001, 210422001, 210622001, 230222001, 230622001, 240122001, 240522001, 260522001, 260722001, 260722002, 261121001, 261221001, 270122001, 270422001, 270422002, 270522001, 270622001, 271121001, 280222002, 280622001, 290522001, 290622001, 291221001, 300322001, 300622002, 301121001, 301221001, 310322001, 310522001. ***EXPANSION 09/08/2023, Serial Numbers: 220523002, 220822001, 131222001, 251122001, 271122001, 100223001, 220423001, 300822001, 30323001, 41222001, 51222001, 91222002, 81222002, 301122001, 180822001, 71222001, 180722001, 220523001, 300523002, 80623001, 30523001, 11122001, 31122001, 81122001, 91222001, 30723001, 211122001, 121222001, 310523001, 40423001, 290323001, 300323001, 141222001, 141222002, 310822001, 40623002, 300922001, 200223001, 90223001, 180523001, 280523001, 240423001, 10623001, 191122001, 61222001, 90623001, 190423001, 70223001, 90223002, 40723001, 130623001, 180423001, 230922001, 260922001, 251022001, 291022001, 200323001, 261022001, 140523001, 160523001.

Distribution pattern

US Nationwide