FDA-Device2014-01-15Class II
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
Trans American Medical, Inc.
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.
Sold states
US Distribution: including states of: WA and UT.
Affected count
68
Manufactured in
965 W 325 N, Lindon, UT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0532-2014Don't want to check this manually?
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