FDA Medical Device Recalls (openFDA)
Carl Zeiss Suzhou Co., Ltd.: OPMI LUMERA 300, REF 6137
- Recall number
- Z-0183-2024
- Recalling firm
- Carl Zeiss Suzhou Co., Ltd.
- Product
- OPMI LUMERA 300, REF 6137
- Status
- Open, Classified
- Initiated
- 2023-08-18
- Posted
- 2023-10-26
- Terminated
- not on file
- 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 (repair if needed) of the suspension arm. Complete and return the acknowledgement and receipt form and return to USFCA.meditec.us@zeiss.com If you have any questions, contact firm Customer Support at 877-486-7473.
- Quantity
- 8
- Distribution
- US Nationwide distribution in the states of MD, TX, CA, GA, LA.
- Lot, serial or model codes
- UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSO
- Firm FEI
- 3008564898
- Firm city
- Suzhou
- Firm state
- Kunshan
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28