Recall Z-0183-2024 ยท FSO Microscope, Surgical, General & Plastic Surgery
Carl Zeiss Suzhou Co., Ltd.
OPMI LUMERA 300, REF 6137
| Date | Oct 26, 2023 (initiated Aug 18, 2023) |
| Status | Open, Classified |
| Reason | Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components. |
| Root cause | Process control |
| Action | On 8/18/23, correction notices were mailed to customers who were asked to do the following: Before each use of the affected device, perform the following mandatory inspection: Refer to pictures in the notice showing a gap between the OPMI and the inspection arm. This gap should not be greater than 5mm. If the gap is greater than 5mm, please Immediately stop using the device! In this case the affected device can no longer be used. The firm is planning to inspect (repair if needed) the suspension arm immediately. Service staff will contact you to arrange an appointment for inspection (repa |
| Quantity | 8 |
| Distribution | US Nationwide distribution in the states of MD, TX, CA, GA, LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.