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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 Device Recall Spectre Wireless Footswitch/Handswitch system see related information
Date Initiated by Firm August 22, 2013
Date Posted January 03, 2014
Recall Status1 Terminated 3 on December 29, 2015
Recall Number Z-0532-2014
Recall Event ID 66064
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 UT 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		 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 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.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = TRANSAMERICAN MEDICAL IMAGING
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