DigitalDiagnost C50Recalls & reported problems across all models

We found 2 models of DigitalDiagnost C50 by Philips Healthcare (Suzhou) Co., Ltd. in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2022 and Jun 3, 2026 — classified as 2 injuries, 11 malfunctions.

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

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

DigitalDiagnost C50 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

2. 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-1382-2023 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported DigitalDiagnost C50 problems

DigitalDiagnost C50 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DigitalDiagnost C50

  System, x-ray, stationary
  1 recall8 reports
• DigitalDiagnost C50

  System, x-ray, stationary
  1 recall5 reports

Recent DigitalDiagnost C50 adverse event reports

The 13 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Unintended System Motion

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. IT WAS REPORTED THAT THE COUNTERBALANCE WAS NOT SUFFICIENT AND THE TUBE DESCENDED DOWNWARD WHEN TURNING THE SYSTEM OFF. WHILE THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY IN THIS SPECIFIC CASE, SIMILAR EVENTS INVOLVING THIS ISSUE HAVE RESULTED IN SERIOUS INJURY IN THE PAST. THEREFORE, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25369799 ↗
• MalfunctionFeb 9, 2026Mechanical Jam; Device Difficult to Maintain

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE REPORTED ISSUE IS THAT THE TUBE IS TOO HEAVY TO MOVE WITH INCREASED RESISTANCE. AS A RESULT, THE USER HAS REPORTED EXPERIENCING PAIN IN THE ARMS, SHOULDERS AND NECK. THE USER HAS BEEN ON ACC NZ LEAVE FOR FOUR DAYS, RECEIVING TREATMENT FROM A PHYSIOTHERAPIST AND GP, AND HAS BEEN ADVISED TO CONSULT A SPECIALIST FOLLOWING AN MRI SCAN. THE FULL EXTENT OF THE INJURY IS CURRENTLY UNDER EVALUATION. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: Pain

  MAUDE report 24290194 ↗
• 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 ↗
• MalfunctionMar 12, 2024Unintended System Motion; Unintended System Motion

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. CUSTOMER REPORTED THAT AFTER THE SHUTTING THE SYSTEM DOWN, TUBE HEAD AUTOMATICALLY FELL DOWN. THIS EVENT WAS IDENTIFIED OUTSIDE OF CLINICAL USE, DURING REGULAR SHUT DOWN OF THE SYSTEM. HOWEVER, THIS MALFUNCTION WOULD POTENTIALLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THIS WERE TO RECUR. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.PHILIPS HAS STARTED THE INVESTIGATION OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891775 ↗
• MalfunctionNov 5, 2023Unintended System Motion; Unintended System Motion

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS BALL TUBE DROPPED FROM TELESCOPIC TO THE LOWEST POSITION AND HIT THE EXAMINATION TABLE AFTER AN EXTERNAL POWER OUTAGE WHILE DEVICE WAS SITTING IDLE. THIS MALFUNCTION WOULD LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THIS WERE TO RECUR. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS COMPLETED THE INVESTIGATION OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070842 ↗
• MalfunctionOct 24, 2023Unintended System Motion; Unintended System Motion

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THE ISSUE REPORTED WAS THAT TUBE DESCENDED WHEN THE USER WAS MANUALLY ADJUSTING THE TUBE HEIGHT FOR A WALL STAND SCAN. THERE WAS NO INJURY/HARM HAPPENED IN THIS CASE. THIS MALFUNCTION WAS NOT LIKELY TO CAUSE DEATH OR SERIOUS INJURY IF IT WERE TO RECUR BASED ON THE RISK EVALUATION RESULT. THEREFORE, THIS ISSUE HAS BEEN DETERMINED NOT TO BE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993494 ↗
• 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 ↗

Other Philips Healthcare (Suzhou) Co., Ltd. products

• Incisive CT2 models · 25 reports · 16 recalls
• DuraDiagnost2 models · 1 reports · 2 recalls