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U.S. Department of Health and Human Services

Class 2 Device Recall multiple Laser Scanning Microscopes.

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  Class 2 Device Recall multiple Laser Scanning Microscopes. see related information
Date Initiated by Firm May 08, 2018
Date Posted June 09, 2018
Recall Status1 Terminated 3 on April 21, 2020
Recall Number Z-2058-2018
Recall Event ID 80115
Product Classification Spectroscopy instrument - Product Code REM
Product Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple
Laser Scanning Microscopes.
Laser scanning microscopes are used in cell biology research.
Code Information Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes
Recalling Firm/
Manufacturer		 Zeiss, Carl Inc
1 Zeiss Dr
Thornwood NY 10594-1939
For Additional Information Contact
914-747-1800
Manufacturer Reason
for Recall		 In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action 1.Your firm will send an initial email to all known users advising them of the issue, the risk involved and associated mitigations until the units can be evaluated by Carl Zeiss service representatives, 2.Your firm will send a second written communication to each first line purchaser and to each known user site with the notice of action and warning to discontinue use of the component until it has been verified as defective or properly functioning, and 3.Your firm will dispatch factory trained service representatives to perform verification tests and to replace defective units as necessary, free of charge. CDRH approves the CAP subject to the following conditions: For further questions, please call (914) 747-1800.. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Corrective actions will be provided at no cost to the purchasers and completed by March 1, 2019.
Quantity in Commerce 1070 units to US
Distribution USA (nationwide)
Total Product Life Cycle TPLC 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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