Leica Surgical Operating Microscopes recall: Software Issue
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Why was Leica Surgical Operating Microscopes 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 30622001, 41221001, 100522001, 50322001, 60522001, 11221001, 301121001, 20622001, 191121001, 91221001, 61221001, 81221001, 281121001, 291121001, 181121001, 300522001, 71221001, 20322001, 30322001, 60322001, 61221002, 21221001, 241121001, 101221001, 251121001, 31221001, 261121001, 91221002, 101221002, 51221001,
- Product
- Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
- Recalling firm
- Leica Microsystems, Inc.
- Quantity
- 30 devices
- Distribution
- US Nationwide distribution.
- Recall date
- October 5, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)