FDA Medical Device Recalls (openFDA)
Zeiss, Carl Inc: Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The Laser-TIRF Imaging-System is a Class 3B laser system. The Laser TIRF Imaging System allows the visualization of substances or molecules being capable of fluorescing (excitable by light) by means of an electromagnetic (evanescent) field produced by total internal reflection.
- Recall number
- Z-1128-2012
- Recalling firm
- Zeiss, Carl Inc
- Product
- Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The Laser-TIRF Imaging-System is a Class 3B laser system. The Laser TIRF Imaging System allows the visualization of substances or molecules being capable of fluorescing (excitable by light) by means of an electromagnetic (evanescent) field produced by total internal reflection.
- Status
- Terminated
- Initiated
- 2011-04-28
- Posted
- 2012-02-29
- Terminated
- 2012-12-11
- Reason
- The manufacturer confirmed that the opto-semiconductor sensors can be triggered by exposure to incandescent lighting. The safety interlock is in place to prevent unintended exposure to Class 3B laser radiation.
- Root cause
- Nonconforming Material/Component
- Action
- Carl Zeiss MicroImaging LLC, through trained personnel, first visited each user site, provided additional user instructions, re-labeled the components to provide adequate instruction and warning and further placed a label over the access to the locking screw which secures the component to the microscope. Carl Zeiss Inc. issued "IMPORTANT LASER SAFETY NOTICE: URGENT: FIELD CORRECTIVE ACTION" notices to each user by express courier in late April 2011, Carl Zeiss personnel will confirm that the relabeling has been performed and updated instructions for use have been provided. For questions, please contact the company. The firm will implement 2 actions. Service Representatives will visit each user site, provide additional user instructions, relabel the components to provide adequate instruction and warning, and add a label over the access to the locking screw which secures the component to the microscope. Secondly, when new replacement sensors are available, Carl Zeiss field service technicians will perform the component replacements. Modified components are anticipated to be available within 6 months and replacement completed by April 2012.
- Quantity
- 100 units
- Distribution
- Worldwide Distribution -- USA (nationwide)
- Lot, serial or model codes
- All units manufactured are subject to correction.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REK
- Firm FEI
- 2431026
- Firm city
- Thornwood
- Firm state
- NY
- Firm country
- not on file
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