DigitalDiagnost C50 (REF 712201)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884838082366), received between Oct 24, 2023 and Jun 3, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (4 reports).

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

3 other recalls cover devices cleared under the same FDA submission (K163410); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1382-2023 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, 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 ↗
• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163410. One submission often covers many models, so check the product and lot details in each record.

• Z-1383-2023 · Mar 9, 2023 · Open, Classified
  DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
• Z-1563-2022 · Feb 25, 2022 · Open, Classified
  DigitalDiagnost C50 1.1
• Z-2498-2019 · Dec 21, 2018 · Terminated
  DigitalDiagnost C50, Stationary X-ray System