The Recall Desk
HighFDA (Devices)·Z-1027-2026·Announced 2026-01-14

Patient monitors recalled over unvalidated intracranial and bladder pressure measurements

Remote Diagnostic Technologies is recalling 7,129 Philips Tempus Pro Patient Monitors because intracranial and bladder pressure measurements have not been tested or validated for accuracy.

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: Scored 3 under the risk-of-harm criterion: the firm states clinical judgment based on unvalidated measurements could lead to incorrect decisions, and no injuries are reported.

Plain-English summary

The Philips Tempus Pro Patient Monitor, REF 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R and 00-1026-R, together with the USB 2-Channel IBP Module, REF 01-2017, and the user and operator manual, is being recalled by Remote Diagnostic Technologies Ltd.

The patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR), but the record states these measurements have not been tested or validated for accuracy. The firm states that if healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.

The record lists 7,129 units, with REF and UDI-DI pairings listed in the enforcement record. Distribution was worldwide, including nationwide in the United States across Arizona, Virginia, Florida, California, Texas, New Mexico, Iowa, New Jersey, Tennessee, Ohio and Kansas among other states. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should follow the firm's instructions.

The recalled product

Product
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Manufacturer
Remote Diagnostic Technologies Ltd.
Category
Medical Device — Patient monitor
Hazard
Affected units
7,129

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)

  • REF/UDI-DI: 00-1004/05060472440624
  • 00-1007/05060472440655
  • 00-1004-R/05060472440020
  • 05060472442901
  • 00-1007-R/05060472440013
  • 05060472442918
  • 00-1024-R/05060472441027
  • 05060472442925
  • 00-1026-R/05060472441058
  • 05060472442932

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

Related recalls

Same manufacturer · Remote Diagnostic Technologies Ltd.

See all →