Z-0532-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2014
- Initiation Date
- August 22, 2013
- Termination Date
- December 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68
Product Description
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
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.
Distribution Pattern
US Distribution: including states of: WA and UT.
Code Information
Serial numbers NS 10324 through NS 10392