Intelli-C Left Side Suspended Table 03400010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05713464000121), received between Feb 28, 2023 and Feb 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K173631); 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. Apr 17, 2024Open, Classified

   X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.

   Z-1784-2024 · Root cause: Device Design · FDA record ↗

2. Apr 27, 2023Open, Classified

   There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.

   Z-1669-2023 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2023Break; Break

  DURING AN EXAMINATION OF A PATIENT, IT WAS FOUND THAT A DRIVE SHAFT IN THE IDE MOVEMENT OF THE INTELLI-C X-RAY DEVICE HAD BROKEN. THE IDE MOVEMENT THAT DRIVES THE DETECTOR INTO POSITION, MOVED UNTIL IT WAS STOPPED BY THE MOVEMENT END STOP. THE EVENT DID NOT CAUSE ANY INJURY TO PATIENT OR OPERATOR AS NO ONE WAS HIT BY THE UNINTENDED MOVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452169 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173631. One submission often covers many models, so check the product and lot details in each record.

• Z-1668-2023 · Apr 27, 2023 · Open, Classified
  Intelli-C, Right side suspended Tabletop, REF: 03400000
• Z-0526-2022 · Jan 21, 2022 · Open, Classified
  1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)