SOMATOM X.ceed 11330002Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04056869231051), received between Sep 8, 2022 and Apr 16, 2026 — classified as 1 death, 2 injuries, 4 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K211373, K233650); 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. Dec 19, 2025Open, Classified

   To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

   Z-1239-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT AN INCIDENT OCCURRED WHILE OPERATING THE SOMATOM X.CEED CT-SYSTEM. DURING A STROKE EXAMINATION OF AN 82-YEAR-OLD MALE PATIENT, THE PATIENT WAS RESTLESS AND DIFFICULT TO POSITION. THE PERFUSION SCAN INCLUDING CONTRAST MEDIUM WAS PERFORMED THREE TIMES. BECAUSE THE CUSTOMER COULD NOT EVALUATE THE DATA MANUALLY, NEITHER AFTER THREE SCANS, AN ADDITIONAL MRI EXAMINATION WAS PERFORMED TO RULE OUT A STROKE. THE THREE SCANS TOOK ABOUT 28 MINUTES, WHICH IS RATED AS THE DELAY IN DIAGNOSIS FOR THE PATIENT. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895411 ↗
• InjuryNov 4, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM X.CEED CT SYSTEM. VARIAN REPORTED THAT A PHYSICIAN WAS USING THE SIEMENS HEALTHINEERS MYNEEDLE LASER TO PLAN AND PLACE THE VARIAN IB MW (INTELLIBLATE MICROWAVE) NEEDLES. FOLLOWING THE PLACEMENT, IMAGING REVEALED THAT THE NEEDLES WERE NOT POSITIONED AS INTENDED, RESULTING IN A PARTIAL PNEUMOTHORAX OF THE PATIENT¿S RIGHT LUNG. TO ADDRESS THE COMPLICATION, THE PHYSICIAN INSERTED A 10F CHEST DRAIN, AND THE PROCEDURE CONTINUED WITHOUT FURTHER ADVERSE HEALTH EFFECTS FOR THE PATIENT.

  Patient problems: Pneumothorax

  MAUDE report 23465951 ↗
• MalfunctionJul 2, 2025Unintended Movement; Unintended Movement

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE SOMATOM X. CEED UNIT. THE USER REPORTED TWO INSTANCES WHEN THE SYSTEM TABLE CONTINUED MOVING WITHOUT GIVEN COMMAND AND BUMPED INTO A STAFF MEMBER. THERE ARE NO INJURIES ASSOCIATED WITH THE REPORTED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382374 ↗
• MalfunctionOct 2, 2024Computer Software Problem; Application Program Freezes or Fails to Launch; Computer Software Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM X. CEED CT SYSTEM. ON (B)(6) 2024, A CRITICAL PATIENT WITH INTERNAL BLEEDING WAS ON THE SCANNER TO IDENTIFY THE SOURCE OF BLEEDING WITH A THREE PHASES ABDOMEN THORAX SCAN. THE NATIVE SCANS (TOPOGRAM-, SPIRAL, AND SEQUENCE SCAN) WERE COMPLETED SUCCESSFULLY BUT THE BOLUS TRACKING WAS NOT POSSIBLE. A FAILURE MESSAGE WAS SHOWN TO THE OPERATOR. AS A RESULT, THE PATIENT WAS TAKEN TO IMMEDIATE SURGERY WITHOUT ANY FURTHER DIAGNOSTIC IMAGES AS THE SITUATION WAS RATED AS LIFE-THREATENING. CURRENTLY WE ARE NOT AWARE OF ANY FURTHER PATIENT RELATED INFORMATION. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351916 ↗
• InjuryAug 10, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM X.CEED CT SYSTEM. THE IN-HOSPITAL PATIENT WAS NOT ABLE TO STRAIGHTEN HIS KNEE SO THE OPERATOR POSITIONED THE PATIENT WITH HIS RIGHT KNEE BENT. PRIOR TO THE SCAN, THE OPERATOR CHECKED THAT THE PATIENT WOULD FIT IN THE SCANNER WELL WITH HIS KNEE BENT. AFTER THE COMPLICATION-FREE TOPOGRAM, THE OPERATOR STARTED THE EXAMINATION SCAN. ONCE TABLE MOVEMENTS BEGAN, THE PATIENT FURTHER BENT HIS KNEE CAUSING HIS RIGHT KNEE TO COME IN CONTACT WITH THE PLEXI RING IN THE GANTRY AND MOVING PARTS OF THE GANTRY TOUCHED THE PATIENT'S KNEE. THE EXAM WAS IMMEDIATELY STOPPED AND THE PATIENT WAS REMOVED FROM THE SCANNER. THE PATIENT SUFFERED A LACERATION TO HIS RIGHT KNEE APPROXIMATELY 2-3 INCHES IN LENGTH IN A DIAGONAL DIRECTION WHICH REQUIRED STITCHES. FOLLOWING TREATMENT, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. WE ARE UNAWARE OF ANY FURTHER IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

  Patient problems: Laceration(s)

  MAUDE report 17497599 ↗
• MalfunctionSep 20, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM X.CEED CT SYSTEM. IT WAS REPORTED THAT THE ILG LASERS SELECTION FOR NEEDLE PATH DISPLAY WAS NOT SUITABLE FOR THE GIVEN PATIENT CONTOUR. THE ENTRY POINT WAS COVERED BY THE PATIENT AND THE "EXIT" POINT WAS VISIBLE INSTEAD. THE CLINIC STAFF PREPARED THE PATIENT FOR INTERVENTION BASED ON THE INCORRECTLY DISPLAYED LASER MARK. PREPARATION WAS REPEATED WHEN THE PHYSICIAN RECOGNIZED THE OBVIOUS DISCREPANCY BETWEEN PLANNED AND VISUALIZED ENTRY POINT. THIS PROBLEM MAY OCCUR IN SPECIAL (RARE) COMBINATIONS OF PATIENT CONTOUR AND PLANNED NEEDLE PATH. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454732 ↗
• DeathSep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM XCEED CT SYSTEM. ON (B)(6) 2022, AN 82-YEAR-OLD FEMALE PATIENT UNDERWENT AN ABDOMEN AND PELVIS EXAMINATION WITH CONTRAST MEDIA. THE PATIENT WAS PLACED ON THE TABLE AND COMPLAINED OF DIFFICULTY BREATHING. CT TECHNICIANS READJUSTED THE PATIENT BY RAISING THE PATIENT UP A BIT AND THE EXAM PROCEEDED WITH FIRST SCAN. THE TECHNICIAN THEN ENTERED THE ROOM TO ADMINISTER CONTRAST; AT WHICH TIME THE PATIENT WAS STILL FINE. AFTER THE BREATH HOLD PORTION OF THE SCAN, THE PATIENT COMPLAINED OF BREATHING DIFFICULTY AGAIN. CT TECHNICIANS ATTEMPTED TO REMOVE THE PATIENT FROM THE MACHINE, HOWEVER THE MACHINE FAULTED WITH AN ERROR STATING "STOP BUTTON HAS BEEN PRESSED, PRESS RESUME TO CONTINUE". ANOTHER CT TECHNICIAN CONTINUED PRESSING 'RESUME' WHILE THE PATIENT ATTEMPTED TO GET OFF THE TABLE THEMSELVES. THE CT TECHNICIANS WERE NOT ABLE TO PULL THE TABLE OUT OF THE BORE DURING THIS TIME. APPROXIMATELY 15-30 SECONDS LATER, THE SYSTEM TURNED BACK ON, AND THEY WERE ABLE TO PULL THE TABLE OUT OF THE GANTRY, AT WHICH TIME THE PATIENT WAS SET UPRIGHT ON THE TABLE. ACCORDING TO INFORMATION PROVIDED TO SIEMENS, THE PATIENT

  Patient problems: Respiratory Arrest

  MAUDE report 15378163 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211373, K233650. One submission often covers many models, so check the product and lot details in each record.

• Z-1003-2023 · Dec 22, 2022 · Open, Classified
  Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.
• Z-0962-2022 · Mar 7, 2022 · Open, Classified
  SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM
• Z-0995-2022 · Mar 7, 2022 · Terminated
  syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo