Patient monitors recalled over unvalidated intracranial and bladder pressure measurements

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

• unvalidated-measurement
• intracranial-pressure
• clinical-decision-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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