DigitalDiagnost C50 (REF 712204)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884838095199), received between Jul 19, 2022 and Jul 3, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K201725); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 9, 2023Open, Classified

   If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users

   Z-1383-2023 · Root cause: Equipment maintenance · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Mechanical Problem; Mechanical Problem

  THIS COMPLAINT WAS REVIEWED. THE CUSTOMER REPORTED OBSERVING SHAVINGS DESCENDING FROM THE RAILS. THERE'S NO ALLEGATION OF DEATH OR SERIOUS INJURY. HOWEVER, CONSIDERING THAT A SIMILAR INCIDENT HAS PREVIOUSLY OCCURRED ON THE SAME DEVICE LEAD TO AN EYE INJURY, THIS EVENT HAS BEEN DETERMINED TO BE A REPORTABLE ONE. PHILIPS HAS STARTED THE INVESTIGATION OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392517 ↗
• MalfunctionApr 27, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE OVERHEAD TUBE FELL DOWN DUE TO DEFECTIVE CABLE CORRUGATE SUPPORT. THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. HOWEVER, IT IS UNCERTAIN WHETHER THIS EVENT IS LIKELY TO RECUR AND POTENTIALLY CAUSE SERIOUS INJURY. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS INITIATED AN INVESTIGATION INTO THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915810 ↗
• MalfunctionApr 27, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CABLE CORRUGATED SUPPORT HAS COLLAPSED. ISSUE OCCURRED OUTSIDE OF CLINICAL USE; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. HOWEVER, IT IS UNCERTAIN WHETHER THIS EVENT IS LIKELY TO RECUR AND POTENTIALLY CAUSE SERIOUS INJURY. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS INITIATED AN INVESTIGATION INTO THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915807 ↗
• MalfunctionMar 21, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE POSITIONING OF THE CEILING SUSPENSION, THE HANGER FAILED, CAUSING HEAVY CABLES TO FALL FROM THE CEILING. THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. HOWEVER, IT IS UNCERTAIN WHETHER THIS EVENT IS LIKELY TO RECUR AND POTENTIALLY CAUSE SERIOUS INJURY. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS INITIATED AN INVESTIGATION INTO THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663441 ↗
• MalfunctionMar 12, 2025Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED THAT THE CORRUGATED HOSE HAS FELL OVER THE TABLE WHILE A PATIENT WAS ON IT DURING PROCEDURE. HOSE WAS LAYING LOW BUT STILL ABLE TO WORK. THERE'S NO ALLEGATION OF DEATH OR SERIOUS INJURY, HOWEVER, IT IS UNCERTAIN WHETHER THIS EVENT IS LIKELY TO RECUR AND CAUSE A SERIOUS INJURY. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS STARTED THE INVESTIGATION OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580630 ↗
• MalfunctionFeb 10, 2025Mechanical Problem; Mechanical Problem

  THE ISSUE REPORTED WAS THE CABLE HOSE HOLDER CAME LOOSE AND HOSE DROPPED. THERE'S NO ALLEGATION OF DEATH OR SERIOUS INJURY. HOWEVER, IT IS UNCERTAIN WHETHER THIS EVENT IS LIKELY TO RECUR AND CAUSE A SERIOUS INJURY. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343683 ↗
• InjuryFeb 10, 2025Flaked; Mechanical Problem; Flaked; Mechanical Problem

  THE CUSTOMER REPORTED THAT DURING THE POSITIONING OF THE C50 CEILING SUSPENSION FOR A PATIENT'S X-RAY, THE TECHNICIAN, WHILE LOOKING UP TO MOVE THE TUBE, SUSTAINED AN INJURY WHEN A FLAKE OR SLIVER OF METAL ENTERED HER EYE. DESPITE WEARING GLASSES, THE METAL FLAKE CAUSED IRRITATION AND BECAME "EMBEDDED IN THE EYE." THE DOCTOR HAD TO REMOVE PART OF THE METAL FLAKE, WITH FOLLOW-UP TREATMENT REQUIRED TO REMOVE THE REMAINING FRAGMENT. UPON EXAMINATION OF THE EQUIPMENT, IT WAS NOTED THAT "METAL FLAKES WERE FOUND SURROUNDING THE TUBE HEAD BASE AND HAD ORIGINATED FROM THE TOP RAILS OF THE CEILING SUSPENSION." BASED ON AVAILABLE INFORMATION, THE REPORTED EVENT (METAL FLAKE IN THE EYE REQUIRING REMOVAL X2 TO PREVENT PERMANENT DAMAGE) MEETS CRITERIA FOR SERIOUS INJURY. THEREFORE, THIS EVENT HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS STARTED THE INVESTIGATION OF THIS EVENT.

  Patient problems: Corneal Scar; Eye Injury; Eye Irritation; Foreign Body Sensation in Eye

  MAUDE report 21343352 ↗
• InjuryJul 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN ANKLE EXAM ON THE EXAM BED. THE EQUIPMENT WAS POWERED OFF, AND THE TUBE WAS SUSPENDED AND PRESSED DOWN ON THE PATIENT. THE PATIENT BELIEVED THAT THE ANKLE FRACTURE WAS CAUSED BY THE PRESSURE OF OUR PHILIPS EQUIPMENT. THE PATIENT THINKS THAT OUR PHILIPS EQUIPMENT WAS PRESSED DOWN AND CAUSED THE ANKLE FRACTURE. NOW THE HOSPITAL ASKS: IF THE PATIENT CANNOT ACCEPT THE HOSPITAL'S EXPLANATION, THE HOSPITAL NEEDS PHILIPS TO COOPERATE WITH THE EXPLANATION. PATIENT BELIEVES HE HAS BEEN HARMED. SUDDEN POWER FAILURE DURING NORMAL OPERATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 15051938 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201725. One submission often covers many models, so check the product and lot details in each record.

• Z-1382-2023 · Mar 9, 2023 · Open, Classified
  Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
• Z-1563-2022 · Feb 25, 2022 · Open, Classified
  DigitalDiagnost C50 1.1