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U.S. Department of Health and Human Services

Class 2 Device Recall Point Scanning Confocal Microscope TCS SP5/TCS SP5 X

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 Class 2 Device Recall Point Scanning Confocal Microscope TCS SP5/TCS SP5 Xsee related information
Date Initiated by FirmNovember 12, 2009
Date PostedMay 06, 2010
Recall Status1 Terminated 3 on May 11, 2010
Recall NumberZ-1221-2010
Recall Event ID 54165
Product Classification Spectroscopy Instrument - Product Code REM
ProductShutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Laboratory instrument.
Code Information Shutter HX SP5, Material No: 1531160006 Spare Part No: 15000904000093
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
2345 Waukegan Rd
Bannockburn IL 60015-1515
For Additional Information Contact
847-405-6565
Manufacturer Reason
for Recall		A manufacturing defect was identified that could potentially result in the laser shutter not closing as intended which could result in the shutter not completely closing disrupting the laser beam safely.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionA Service Note was sent to service organizations on November 12, 2009. The communication asked customers to check if they must exchange their shutters and send their planned exchange date by 2009-11-20 to clsm.qc@leica-microsystems.com. Customers were also asked to check the serial numbers of the one-wire chips of the shutters. Then lastly, the were asked to exchange the shutters and confirm the exchange.
Quantity in Commerce15 microscopes and 8 spare part shutters
DistributionWorldwide Distribution -- USA, Sweden, Japan, Hong Kong, Italy, the Netherlands, Singapore, UK, and Spain.
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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