Recall Z-1850-2022— Leica Microsystems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2022-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737. Reason: 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..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-26
- Firm location
- deerfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.