Mobilett XP hybrid 01818454Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869009094), received between Oct 28, 2020 and Apr 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K033238); 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 18, 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.

• MalfunctionApr 1, 2022Mechanical Problem; Mechanical Problem

  SIEMENS BECAME AWARE OF AN INCIDENT WITH THE MOBILETT XP UNIT. THE COLLIMATOR DETACHED DURING AN EXAMINATION IN THE NEONATAL UNIT. THIS WAS CAUSED BY DETACHMENT OF THE FLANGE THAT HOLDS THE COLLIMATOR FROM THE SINGLE TANK. THERE WAS NO INJURY ATTRIBUTED TO THE EVENT. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13976876 ↗
• MalfunctionOct 28, 2020Electrical /Electronic Property Problem; Sparking; Electrical /Electronic Property Problem; Sparking

  SIEMENS WAS INFORMED ABOUT SPARKS THAT WERE GENERATED FROM THE POWER PLUG WHILE CHARGING THE MOBILETT XP HYBRID DEVICE. THERE IS NO PATIENT INVOLVEMENT IN THE REPORTED CASE. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10747234 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033238. One submission often covers many models, so check the product and lot details in each record.

• Z-1985-2014 · May 9, 2014 · Terminated
  Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and pre
• Z-0171-2011 · Oct 4, 2010 · Terminated
  Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobile
• Z-0718-2011 · Oct 4, 2010 · Terminated
  Mobilett XP Hybrid/Digital/CR Intended use: mobile x-ray system
• Z-0749-2007 · Mar 21, 2007 · Terminated
  Mobilett XP, mobile X-ray system, Model number 1818454