The Recall Desk
HighFDA (Devices)·Z-0861-2022·Announced 2022-04-13

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.

What this means for you

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
  • unapproved-device

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

Distributed nationwide across the United States.

Related recalls

Same category