RecallRadar

FDA Device recall Z-0532-2014

Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch Syst…

On 2014-01-15 the FDA classified a Class II recall of Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch Syst… by Trans American Medical, citing 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 safe….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0532-2014
ClassificationClass II
Statusterminated
Initiated2013-08-22
Published2014-01-15
Last updated2026-09-13 11:53 UTC
CompanyTrans American Medical
DistributionUT, WA

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

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.

Identifiers

code_infoSerial numbers NS 10324 through NS 10392

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0532-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.