Defibrillator devices unapproved for US market recalled by FDA
Remote Diagnostic Technologies recalls Tempus LS defibrillators not approved for US distribution. Two units were distributed in Illinois and Kansas.
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: This is an FDA Class II recall of unapproved medical devices. No illnesses or injuries have been reported. The recall addresses regulatory non-compliance rather than known failures or incidents, warranting a High severity rating for risk-of-harm devices lacking proper FDA clearance.
Plain-English summary
Remote Diagnostic Technologies Ltd. is recalling Tempus LS Type DGE1 defibrillators because they were distributed in the United States without FDA approval or clearance. These devices have not been reviewed and cleared for safe and effective use in the US market.
Two units were distributed: serial numbers 7021.002073 and 7021.002074. Distribution occurred in Illinois and Kansas.
If you have one of these defibrillators, contact Remote Diagnostic Technologies Ltd. or the facility where you obtained it. Do not use the device and follow instructions for safe return or proper handling.
The recalled product
- Product
- Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
- Manufacturer
- Remote Diagnostic Technologies Ltd.
- Category
- Medical Device — Defibrillator
- Hazard
- Affected units
- 2
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)
- Device Serial Numbers 7021.002073 and 7021.002074
Distribution
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