Philips Tempus LS-Manual Defibrillator pacing failure due to communication error
A communication failure in the Philips Tempus LS-Manual Defibrillator may prevent pacing delivery. The device displays an error message and potentially becomes ineffective, affecting approximately 1,147 units distributed nationwide.
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: FDA Class II recall of a critical cardiac device with potential loss of pacing function. No reported injuries or hospitalizations in source material. Meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Philips Tempus LS-Manual Defibrillator, Part Number 00-3020, is subject to a recall due to a potential communication failure between the device's mainboard and its defibrillator/pacemaker module (DPM). When this failure occurs, the device may deliver no pacing or ineffective pacing and will display an error message reading "HW failure DPM."
Approximately 1,147 units are affected by this recall. The affected devices have serial numbers prior to 7022.001634 and were distributed nationwide across nine U.S. states: Utah, Colorado, California, Nebraska, Illinois, Texas, West Virginia, Kansas, and Georgia.
Healthcare providers and individuals using affected units should discontinue use and contact Remote Diagnostic Technologies Ltd., the manufacturer, for information on replacement or repair. Patients dependent on these devices for cardiac pacing should immediately consult with their healthcare provider to discuss alternative pacing options.
This Class II recall was issued by the U.S. Food and Drug Administration under recall number Z-1825-2023.
The recalled product
- Product
- Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
- Manufacturer
- Remote Diagnostic Technologies Ltd.
- Hazard
- device-malfunction
- communication-failure
- pacing-failure
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)
- UDI-DI: 07613365002737. Serial numbers prior to 7022.001634
Distribution
Distributed nationwide across the United States.
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