CLASS II Device recall · Reported 15 Jan 2014 · FDA Enforcement Report
Spectre Wireless Footswitch/Handswitch system recalled
Trans American Medical is recalling Spectre Wireless Footswitch/Handswitch system, distributed in Utah, Washington. The recall was initiated on 22 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0532-2014
- FDA event ID
- 66064
- Recalling firm
- Trans American Medical, Lindon, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Aug 2013
- FDA classified
- 3 Jan 2014
- Reported
- 15 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Aug 2013 | Recall initiated by company | |
| 3 Jan 2014 | Classified by FDA | +134 days |
| 15 Jan 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
US Distribution: including states of: WA and UT.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial numbers NS 10324 through NS 10392
Where was it sold?
US Distribution: including states of: WA and UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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