ProxiDiagnost N90 706100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884838085619), received between Dec 17, 2020 and Apr 22, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

4 FDA recall records name this device's identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 15, 2023Class IIOpen, Classified

   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)

   Z-1072-2024 · Root cause: Software design · Recall details · FDA record ↗

2. Sep 21, 2023Class IIOpen, Classified

   Potential for units suspended on the ceiling to fail and fall.

   Z-0280-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Oct 21, 2022Class IIOpen, Classified

   Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable. If the tabletop cable breaks, the user may not be able to initiate table tilting movements or braking

   Z-1477-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

4. Oct 21, 2021Class IIOpen, Classified

   If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.

   Z-1356-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PIECE OF THE FOOTBOARD WAS MISSING, RESULTING IN EXPOSED PARTS AND A POTENTIAL SAFETY CONCERN. THE DEVICE WAS OUTSIDE OF USE AND THERE WAS NO HARM TO THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956411 ↗
• InjuryFeb 17, 2026Mechanical Jam

  IT WAS REPORTED THAT THE WALKING MECHANISMS LOCK, AND WHEN MOVING FROM ONE SIDE OF THE ROOM TO ANOTHER, THE BUTTON CAN BE PUSHED TO MOVE FROM SIDE TO SIDE. WHEN PULLING IT ACROSS THE ROOM, IT JERKED THE STAFF'S ARM, CAUSING SHOULDER DAMAGE. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT HARM.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 24373816 ↗
• MalfunctionJun 18, 2025Electrical /Electronic Property Problem; Smoking; Electrical /Electronic Property Problem; Smoking

  IT WAS REPORTED THAT ELECTRICAL PART IN M-CABINET BURNED UP. THE USE OF DEVICE WAS UNKNOWN AND THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22269657 ↗
• MalfunctionMar 22, 2023Misassembled During Installation; Misassembled During Installation

  DURING INSTALLATION OF THE SYSTEM, IT WAS FOUND THAT A COUPLE OF THE RAIL CONNECTION BLOCKS WERE MIS-ALIGNED IN THE CEILING UNISTRUT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591773 ↗
• MalfunctionFeb 7, 2023Flare or Flash; Flare or Flash

  WHILE THE SYSTEM WAS BEING USED FOR A FLUOROSCOPY STUDY, THE MAINS CABINET STARTED MAKING LOUD POPPING SOUNDS ALONG WITH SPARKING, SMOKING, AND AN ELECTRICAL FIRE INSIDE OF THE CABINET. NOBODY WAS INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313564 ↗
• MalfunctionDec 17, 2020Radiation Output Problem; Radiation Output Problem

  DURING ANNUAL PHYSICS TESTING, THE STABILIZED DOSE IS HIGH DURING CONTINUOUS FLUOROSCOPY AND PULSED FLUOROSCOPY FOR 20 AND 30 FRAMES PER SECOND.

  Patient problems: No Patient Involvement

  MAUDE report 11027848 ↗