Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Reported: October 5, 2022 Initiated: August 26, 2022 #Z-1850-2022
Product Description
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
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.
Details
- Recalling Firm
- Leica Microsystems, Inc.
- Units Affected
- 115 devices
- Distribution
- US Nationwide distribution.
- Location
- deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737. Recalled by Leica Microsystems, Inc.. Units affected: 115 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2022. Severity: Moderate. Recall number: Z-1850-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11