Leica Microsystems, Inc. Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Brand
Leica Microsystems, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Leica Microsystems, Inc. is recalling Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 due to During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm sent a Field Safety Notice to its consignees on 08/26/2022 by mail. The notice described the problem and stated that A Leica Microsystems representative will be contacting the consignee's to arrange this no-cost field update of the instrument. The field update will be scheduled to occur at your convenience within the next 6 months. The notice provided the following workaround: "Advice on action to be taken by the user: " You can continue to use the system pending this field update. Based on our analysis the probability is very remote that an unacceptable patient risk will occur due to the incorrect BrightCare Plus functionality caused by the non-conforming photodiode. " However, please ensure that all users of the affected microscope are aware of the Dangers of Use as described in section 3.4 and will follow the directions in section 5.3 ( Illumination ) and section 8 ( Operation ) of the user manual when handling a surgical operating microscope see excerpts below: o 3.4 Dangers of Use : &do not set the light intensity too high. & because if &light intensity is too high, uncontrolled tissue heating may occur. o 5.3 Illumination : &begin with a low light intensity and increase it until an optimum level of illumination is achieved. o 8 Operation : &use the lowest comfortable light intensity. The notice also requested acknowledgement of receipt of the Field Safety Notice as follows: "Please acknowledge receipt of this Field Safety Notice with the digital acknowledgment form by either scanning the QR code in your mobile phone or with the following link: https://forms.office.com/r/1WPXW93ugL."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026