Spectre Wireless Footswitch/Handswitch system Model 98/99 — Class II medical device recall Z-0532-2014
Terminated recall by Trans American Medical, Inc., reported 2014-01-15, distributed in UT, WA. TransAmerican Medical Imaging is recalling certain lots of TMI Spectre Wireless Footswitch/Hand switch for GE
| Recall number | Z-0532-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trans American Medical, Inc., Lindon, UT, United States |
| Recall initiated | 2013-08-22 |
| Classified | 2014-01-03 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2015-12-29 |
| Distributed | UT, WA |
| Quantity | 68 |
| Serial numbers | 10324 |
| Model numbers | 98/99 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0532-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.