FDADecember 15, 2023device

ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

0088483808561900884838103221

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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