Z-0532-2014Class II

Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless...

Name: Z-0532-2014 Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless...
Creator: Trans American Medical, Inc.
Published: 2013-08-22
License: https://open.fda.gov/license/

Trans American Medical, Inc. / initiated 2013-08-22 / Terminated / root cause: design

FDA source

Trans American Medical, Inc. began a recall of Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription... on 2013-08-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0532-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-22
Posted: 2014-01-03
Terminated: 2015-12-29
Recalling firm: Trans American Medical, Inc.
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
Product code: IZL System, X-Ray, Mobile
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: TransAmerican Medical sent an Urgent Medical Device Correction letter dated August 26, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all potential users in their facility are made aware of the safety notification and the recommended actions. If the customers system does produce an uncommanded X-ray, turn the system off immediately. Remove the Spectre Wireless Footswitch and receiver and reinstall the standard OEM footswitch. Follow proper shutdown/system reboot instructions as indicated in the system operator's manual. Customers will be contacted to make arrangements for replacement of their TMi Spectre Wireless Footswitch at no charge. Customers will be provided a new TMI Spectre Wireless Footswitch and instructions on how to return the affected footswitch. Customers with questions were instructed to call 801-796-7335, ext 203.
Quantity in commerce: 68
Distribution: US Distribution: including states of: WA and UT.
Product codes and lots: Serial numbers NS 10324 through NS 10392

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0532-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0532-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-03

Product code IZL

K092713Class IISpectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging / cleared 2010-07-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)