Leica MICROSYSTEMS M530 OHX — Class II medical device recall Z-0477-2023
Ongoing recall by Leica Microsystems, Inc., reported 2022-12-21, distributed nationwide. There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal compo
| Recall number | Z-0477-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Microsystems, Inc., deerfield, IL, United States |
| Recall initiated | 2022-11-21 |
| Classified | 2022-12-09 |
| Reported by FDA | 2022-12-21 |
| Distributed | Nationwide (US) |
| Quantity | 148 units |
| Reason classes | device malfunction |
| Serial numbers | 100122001, 100122002, 100223001, 100322002, 100622001, 100622002, 10622001, 10622002, 10623001, 10822001, 110222001, 110522001, 110822001, 11122001, 111221001, 120222001, 120522001, 121222001, 130122001, 130522001, 130622001, 130623001, 131222001, 140122001, 140222001 and 123 more |
| Model numbers | 10448737 |
Product
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.