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U.S. Department of Health and Human Services

Class 2 Device Recall Spectre Wireless Footswitch/Handswitch system

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 Class 2 Recall
Spectre Wireless Footswitch/Handswitch system
see related information
Date Posted January 03, 2014
Recall Status1 Open
Recall Number Z-0532-2014
Recall Event ID 66064
Premarket Notification
510(K) Number
K092713 
Product Classification System, X-Ray, Mobile - Product Code IZL
Product Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number
Code Information Serial numbers NS 10324 through NS 10392
Recalling Firm/
Manufacturer
Trans American Medical, Inc.
965 W 325 N
Lindon, Utah 84042
For Additional Information Contact Mr. Robert H. Woodward
801-796-7335 Ext. 203
Manufacturer Reason
for Recall
TransAmerican Medical Imaging is recalling certain lots of TMI Spectre Wireless Footswitch/Hand switch for GE OEC 9800/9900 and Philips FDS and FDB Cath Labs due to potential safety issue related to the use of this product producing uncommanded X-ray.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action TransAmerican Medical sent an Urgent Medical Device Correction letter dated August 26, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all potential users in their facility are made aware of the safety notification and the recommended actions. If the customers system does produce an uncommanded X-ray, turn the system off immediately. Remove the Spectre Wireless Footswitch and receiver and reinstall the standard OEM footswitch. Follow proper shutdown/system reboot instructions as indicated in the system operator's manual. Customers will be contacted to make arrangements for replacement of their TMi Spectre Wireless Footswitch at no charge. Customers will be provided a new TMI Spectre Wireless Footswitch and instructions on how to return the affected footswitch. Customers with questions were instructed to call 801-796-7335, ext 203.
Quantity in Commerce 68
Distribution US Distribution: including states of: WA and UT.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = TRANSAMERICAN MEDICAL IMAGING
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