Recall archive / FDA device enforcement
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system — FDA record Z-0477-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 21, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Leica Microsystems, Inc.
- Quantity
- 148 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0477-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
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- California
- Colorado
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- Delaware
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- Hawaii
- Iowa
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- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
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- Tennessee
- Texas
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- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 21, 2022
- Recall initiation date
- Nov 21, 2022
- Center classification date
- Dec 9, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.