Class 2 Device Recall Leica

• Date Initiated by Firm: August 26, 2022
• Date Posted: September 29, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1848-2022
• Recall Event ID: 90818
• Product Classification: Microscope, surgical, general & plastic surgery - Product Code FSO
• Product: Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
• Code Information: 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.
• FEI Number: 3000210133
• Recalling Firm/ Manufacturer: Leica Microsystems, Inc.; 10 Parkway North blvd ste 300; deerfield IL 60089-6622
• For Additional Information Contact: 800-225-8867
• Manufacturer 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.
• FDA Determined Cause: Component change control
• Action: 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."
• Quantity in Commerce: 30 devices
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.