SEDECAL MobileDiagnost wDRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08436046002173), received between Oct 19, 2018 and Oct 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 14, 2021Open, Classified

   While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.

   Z-1083-2024 · Root cause: Use error · 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.

• MalfunctionOct 19, 2018Device Dislodged or Dislocated; Device Fell

  THIS IS A MOBILE DIAGNOSTIC X-RAY UNIT. THE COLLIMATOR ON THE UNIT WAS SERVICED. AS A RESULT OF IMPROPER RE-ATTACHMENT, THE COLLIMATOR FELL OFF THE TUBE-HEAD DURING SUBSEQUENT USE. IT WAS THEN LEFT DANGLING BY ITS CABLE. NO ONE WAS INJURED. A SERVICE PERSON SUBSEQUENTLY RE-ATTACHED THE COLLIMATOR IN A PROPER FASHION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7984277 ↗