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Recall Observatory FDA recall evidence

Device 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

Z-0532-2014

August 22, 2013

Class II

Product summary

Firm
Trans American Medical, Inc.
Event
Event 66064
Status
Terminated
Classification
Class II
Quantity
68
Official record key
device-enforcement:Z-0532-2014

Official wording

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.

Code information: Serial numbers NS 10324 through NS 10392

Distribution pattern: US Distribution: including states of: WA and UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.