Trans American Medical Recalls Spectre Wireless Footswitches Due to Uncommanded X-ray Risk
Trans American Medical is recalling 68 Spectre Wireless Footswitch/Handswitch units because they may produce uncommanded X-rays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of uncommanded X-ray exposure, which is a risk-of-harm product issue where no specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Trans American Medical, Inc. is recalling 68 units of the Spectre Wireless Footswitch/Handswitch system, including Models 98/99, FDS, and FDB. These prescription-use devices are intended for use with specific GE OEC 9800/9900 and Philips FDS and FDB Cath Labs.
The recall is being conducted due to a potential safety issue where the use of the product may produce uncommanded X-rays. The affected units have serial numbers ranging from NS 10324 through NS 10392.
The affected products were distributed in the United States, specifically in the states of Washington and Utah. The source text does not specify further instructions for consumers or healthcare providers regarding the immediate handling of these devices.
The recalled product
- 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
- Manufacturer
- Trans American Medical, Inc.
- Hazard
- Affected units
- 68
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers NS 10324 through NS 10392
Distribution
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