OPMI LUMERA 300, REF 6137
Recall
- Recall Number
- Z-0183-2024
- Event Number
- 93146
- Firm
- Carl Zeiss Suzhou Co., Ltd. Modern Industrial Square
- FEI Number
- 3008564898
- Product Code
- FSO
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- August 18, 2023
- Posted
- October 26, 2023
- Address
- 3b No. 333 Xingpu Road, Kunshan Suzhou China
Description
OPMI LUMERA 300, REF 6137
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.
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 (repair if needed) of the suspension arm. Complete and return the acknowledgement and receipt form and return to [email protected] If you have any questions, contact firm Customer Support at 877-486-7473.
US Nationwide distribution in the states of MD, TX, CA, GA, LA.
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