Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1729-2025·Announced 2025-05-14

Philips Tempus Pro Patient Monitor Software Update for Operational Issues

Remote Diagnostic Technologies Ltd. is issuing a software update for the Philips Tempus Pro Patient Monitor due to freezing, rebooting, and potential ECG measurement accuracy issues across multiple software versions.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a medical device with operational and measurement accuracy issues. No illnesses, injuries, or deaths are reported in the source text. The hazards are operational failures and potential ECG inaccuracy, which are addressed through a voluntary software update without evidence of harm.

Plain-English summary

Remote Diagnostic Technologies Ltd. is recalling software versions prior to vx.40 for the Philips Tempus Pro Patient Monitor (REF models: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007). The device may experience several operational failures: freezing at startup with MPM Application error and Attention Restart Required messages, freezing and rebooting at the start of 12-lead ECG or after the procedure, and rebooting after intermittent connection with Smart Mount.

Additionally, 12-lead ECG measurements using the Louvain algorithm in software versions before vx.40 could produce inaccurate rhythm and morphology statements, potentially affecting clinical decision-making.

Approximately 6,961 units of this patient monitor have been distributed worldwide and throughout the United States, including in 50 states plus Washington DC and multiple countries. Affected customers should update to software version vx.40 or later. Users are advised to contact Remote Diagnostic Technologies Ltd. or their authorized representative for the software update.

The recalled product

Product: Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Manufacturer: Remote Diagnostic Technologies Ltd.
Category: Medical Device — Patient Monitoring
Hazard: device-freeze
software-error
measurement-inaccuracy
reboot-issue
Affected units: 6,961

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)

Software versions prior to vx.40. REF/UDI-DI: 00-1004-R/05060472440020
05060472442901
00-1007-R/05060472440013
05060472442918
00-1024-R/05060472441027
05060472442925
00-1026-R/05060472441058
05060472442932
00-1004/05060472440624
00-1007/05060472440655

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

Same manufacturer · Remote Diagnostic Technologies Ltd.

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Same hazard · device freeze