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U.S. Department of Health and Human Services

Class 2 Device Recall DirectFRAP (Direct Flourescence Recovery After Photobleaching

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 Class 2 Device Recall DirectFRAP (Direct Flourescence Recovery After Photobleachingsee related information
Date Initiated by FirmApril 28, 2011
Date PostedFebruary 29, 2012
Recall Status1 Terminated 3 on December 11, 2012
Recall NumberZ-1129-2012
Recall Event ID 59285
Product Classification Research laser - Product Code REK
ProductDirectFRAP (Direct Flourescence Recovery After Photobleaching) Imaging System is an extension unit for Axio Observer that is used for microscopic analyses of dynamic processes within living cells. The DirectFRAP module is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The DirectFRAP Imaging System is a Class 3B laser system. The DirectFRAP Imaging System is a laser manipulation slider which allows coupling of laser light simultaneously with the conventional fluorescence illumination into the reflected-light beam path of the microscope system. Depending on the application, the laser light is used for the targeted bleaching of fluorophores for FRAP experiments or for the conversion of fluorophores within the cell.
Code Information All units manufactured are subject to correction.   
Recalling Firm/
Manufacturer		 Zeiss, Carl Inc
1 Zeiss Dr
Thornwood NY 10594-1939
For Additional Information ContactScott A. Margolin
914-681-7880
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCarl 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 Commerce11 units
DistributionWorldwide Distribution -- USA (nationwide)
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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