FDAFDA · Food and drugs·Recall number Z-0532-2014
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
Published January 15, 2014 · Recall initiated: August 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Trans American Medical, Inc.
- Distributor
- US Distribution: including states of: WA and UT.
- Lot
- Serial numbers NS 10324 through NS 10392
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.