Z-0532-2014 Class II Terminated
FDA device recall Z-0532-2014 was initiated by Trans American Medical, Inc. on August 22, 2013 and is designated Class II. 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 t… The recall status is terminated (terminated December 29, 2015). Affected quantity: 68.
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