Z-1128-2012

Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component...

Name: Z-1128-2012 Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component...
Creator: Zeiss, Carl Inc
Published: 2011-04-28
License: https://open.fda.gov/license/

Carl Zeiss Microscopy, LLC / initiated 2011-04-28 / Terminated / root cause: manufacturing process

FDA source

Zeiss, Carl Inc began a recall of Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component used in conjunction with Laser Scanning Microscopes... on 2011-04-28. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1128-2012
Status: Terminated
Initiated: 2011-04-28
Posted: 2012-02-29
Terminated: 2012-12-11
Recalling firm: Carl Zeiss Microscopy, LLC
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.
Product code: REK Research Laser
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 100 units
Distribution: Worldwide Distribution -- USA (nationwide)
Product codes and lots: All units manufactured are subject to correction.

Product code REK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)