Z-1849-2022 Class II Ongoing
FDA device recall Z-1849-2022 was initiated by Leica Microsystems, Inc. on August 26, 2022 and is designated Class II. 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 l… The recall status is ongoing. Affected quantity: 25 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2022
- Initiation Date
- August 26, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 devices
Product Description
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Serial Numbers: 210721001, 180721001, 190721001, 121021001, 100821001, 60821001, 90821001, 120821001, 10821001, 80721001, 40821001, 130821001, 290821001, 240821001, 91021001, 180921001, 181121001, 151021001, 190821001, 160921001, 20721001, 50721001, 40921001, 150821001, 160821001