Recall Z-1848-2022 ยท FSO Microscope, Surgical, General & Plastic Surgery
Leica Microsystems, Inc.
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
| Date | Sep 29, 2022 (initiated Aug 26, 2022) |
| Status | Open, Classified |
| 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. |
| Root 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 du |
| Quantity | 30 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.