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Trans American Medical, Inc. recalls Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Foots
Recalled January 15, 2014 · FDA recall Z-0532-2014 · Trans American Medical
Hazard
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 Class II
Units
68
Sold at
US Distribution: including states of: WA and UT.
Description
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.
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
Manufacturer(s)
Trans American Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →