SOMATOM Scope 10046799Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056869013053), received between Jul 8, 2020 and Mar 21, 2023 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K140912); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Defective Component; Manufacturing, Packaging or Shipping Problem; Defective Component; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM SCOPE POWER CT SYSTEM. DURING SYSTEM CALIBRATION WITHOUT ANY PATIENT INVOLVEMENT, THE GANTRY ROTATION BELT BROKE APART. AS A RESULT, IT PUSHED THE PLEXI-RING OUT OF ITS HOLDER AND THE BELT CAME OUT OF THE GANTRY. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED, HOWEVER, IT CANNOT BE EXCLUDED THAT THIS SITUATION COULD HAVE LED TO ANY INJURIES IF A PATIENT WOULD HAVE BEEN ON THE TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585371 ↗
• InjuryApr 23, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT THE PLEXI-RING OF THE CT GANTRY COVER HAS JUMPED OUT OF ITS TRACK DUE TO A MISSING/BROKEN PLASTIC LOCK. THE FACILITY TECHNICIAN ATTEMPTED TO PUSH THE PLEXI-RING BACK INTO ITS ORIGINAL POSITION BUT DID NOT WAIT UNTIL THE GANTRY STOPPED ROTATING. THE TECHNICIAN'S FINGER GOT CAUGHT IN THE ROTATING PARTS AND A MODERATE INJURY TO THE DIGIT WAS SUSTAINED. IT WAS REPORTED THAT BOTH THE SKIN AND MUSCLE OF THE DIGIT WERE INJURED. THE INJURY WAS TREATED BY SUTURING THE LACERATION. THERE WAS NO PERMANENT DAMAGE TO THE TECHNICIAN'S FINGER. THIS INCIDENT IS CONSIDERED A WORK ACCIDENT AND NO MALFUNCTION OR GENERAL DESIGN ISSUE WERE REPORTED. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Laceration(s)

  MAUDE report 11715155 ↗
• DeathMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. THE PATIENT HAD A STRONG ADVERSE REACTION TO THE INJECTED CONTRAST MEDIA BEFORE THE CT SCAN WAS STARTED.

  Patient problems: Death; Hypersensitivity/Allergic reaction

  MAUDE report 11423133 ↗
• MalfunctionJul 8, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT DURING THE EXAMINATION THE UNRESTRAINED PATIENT KICKED THE PLEXI RING AND BROKE IT. THE PATIENT WAS NOT INJURED DURING THE INCIDENT. IT CANNOT BE COMPLETELY EXCLUDED THAT CRITICAL INJURY DUE THE PATIENT CONTACTING THE ROTATING PARTS INSIDE THE GANTRY COULD RESULT IF THIS EVENT WERE TO REOCCUR. THIS REPORT WAS FILED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10245204 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140912. One submission often covers many models, so check the product and lot details in each record.

• Z-2477-2018 · Feb 1, 2018 · Terminated
  SOMATOM Scope Power (Model 10967888)
• Z-2476-2018 · Feb 1, 2018 · Terminated
  SOMATOM Scope ( Model 10967666)