AMX NavigateRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195278003348), received between Nov 7, 2025 and May 5, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Sharp Edges” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K210982); 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Sharp Edges

  ON 06-APR-2026, A GE HEALTHCARE FIELD ENGINEER (FE) WAS ONSITE AT (B)(6) HOSPITAL (USA) PERFORMING SERVICE ON AN AMX NAVIGATE MOBILE X-RAY SYSTEM. DURING THE SERVICE ACTIVITY, THE FE OBSERVED THAT A FASTENER WAS MISSING FROM THE X-RAY TUBE COVER. THE MISSING FASTENER WAS CONFIRMED TO BE THE SAME COMPONENT ASSOCIATED WITH A PREVIOUSLY IDENTIFIED SENTINEL EVENT. NO PATIENT OR USER INJURY WAS REPORTED AT THE TIME OF DISCOVERY. BASED ON THE KNOWN ASSOCIATION WITH A PRIOR SENTINEL EVENT, THIS OCCURRENCE REPRESENTS A REPORTABLE MALFUNCTION, AS RECURRENCE OF THIS MALFUNCTION COULD POTENTIALLY LEAD TO A SERIOUS INJURY IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25080887 ↗
• InjuryNov 7, 2025Sharp Edges; Sharp Edges

  ON (B)(6) 2025, A TECHNOLOGIST AT (B)(6) (USA) REPORTED AN INCIDENT INVOLVING THE AMX NAVIGATE MOBILE X-RAY SYSTEM. WHILE POSITIONING THE X-RAY TUBE FOR A PATIENT EXAMINATION, THE TECHNOLOGIST RIGHT MIDDLE FINGER WAS LACERATED BY A SHARP EDGE ON THE COLLIMATOR FACEPLATE. THE INJURY RESULTED IN A 1.5-INCH CUT, WHICH REQUIRED SIX STITCHES. BASED ON THE TREATMENT ADMINISTERED, THE INJURY IS CLASSIFIED AS SERIOUS.

  Patient problems: Abrasion

  MAUDE report 23498115 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210982. One submission often covers many models, so check the product and lot details in each record.

• Z-2590-2021 · Jun 24, 2021 · Terminated
  AMX Navigate Mobile X-Ray System