Recall Z-0532-2014 ยท IZL System, X-Ray, Mobile
Trans American Medical, Inc.
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
| Date | Jan 3, 2014 (initiated Aug 22, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | TransAmerican Medical sent an Urgent Medical Device Correction letter dated August 26, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all potential users in their facility are made aware of the safety notification and the recommended actions. If the customers system does produce an uncommanded X-ray, turn the system off immediately. Remove the Spectre Wireless Footswitch and receiver and reinstall the standard OEM footswitch. Follow proper shutdown/system reboot instruct |
| Quantity | 68 |
| Distribution | US Distribution: including states of: WA and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092713 | SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM Transamerican Medical Imaging, Jul 16, 2010 |