Agency classClass IIOur severity:High FDA (Devices)·Z-2625-2023·Announced 2023-09-27

Philips Tempus Pro Patient Monitor Software Error Impairs Critical Monitoring

Certain Philips Tempus Pro Patient Monitors may display an error message when laryngoscopes are disconnected, requiring a 60-100 second restart that prevents vital sign monitoring and airway visualization during intubation. This may lead to treatment delays or hypoxia.

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 involving a critical care medical device used during intubation. Although no illnesses or injuries have been reported to date, the error prevents visualization of vital signs and patient airway during a high-stakes critical procedure, creating risk of treatment delay or hypoxia.

Plain-English summary

Philips Tempus Pro Patient Monitors with hardware version Trizeps-7 and software versions 07.26 through 07.30 are subject to this recall. The affected devices include multiple model references (00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007) when used with the Tempus Pro Video Laryngoscope (REF 01-2044). In total, 3,524 units have been identified as affected.

The recalled monitors may display a full-screen error message when the laryngoscope is disconnected, either during or after use. When this error occurs, the device requires 60 to 100 seconds to shut down and restart. During this period, users cannot view graphical patient vital signs, hear the pulse audio tone, or visualize the patient's airway—critical functions during intubation procedures. This malfunction may lead to treatment delays or patient hypoxia.

These monitors have been distributed throughout the United States and internationally. Healthcare facilities using affected devices should contact Remote Diagnostic Technologies Ltd., the recalling manufacturer, for information on software updates or device replacement options.

The recalled product

Product: Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
Manufacturer: Remote Diagnostic Technologies Ltd.
Category: Medical Device — Patient Monitor
Hazard: software-error
monitoring-loss
airway-visualization-loss
hypoxia-risk
treatment-delay
Affected units: 3,524

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 (10)

Monitors with hardware version: Trizeps-7
05060472442901
00-1007-R/05060472440013
05060472442918
00-1024-R/05060472441027
05060472442925
00-1026-R/05060472441058
05060472442932
00-1004/05060472440624
00-1007/05060472440655

Distribution

Distributed in 42 states:

Same manufacturer · Remote Diagnostic Technologies Ltd.

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