Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswit

FDA device recall Z-0532-2014 · posted 2014-01-03 · Terminated

Recall details

Recalling firm

Trans American Medical, Inc.

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

IZL

Quantity affected

68

Distribution

US Distribution: including states of: WA and UT.

Date initiated

2013-08-22

Date posted

2014-01-03

Date terminated

2015-12-29

Location

Lindon, UT

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