Recall Z-0532-2014— Trans American Medical, Inc.

Name: FDA recall Z-0532-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-22

Class II · Terminated

Class II FDA medical device recall by Trans American Medical, Inc., initiated 2013-08-22, terminated 2015-12-29. It names one FDA 510(k) clearance: K092713. 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. Reason: 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..

Recalling firm: Trans American Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-22
Terminated: 2015-12-29
Firm location: Lindon, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K092713 — SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEMTransamerican Medical Imaging·cleared 2010-07-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.