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SOMATOM Scope 10967666Recalls & reported problems

Siemens Shanghai Medical Equipment Ltd. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869010311), received between Aug 25, 2022 and Aug 25, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K140912, K151749, K183548); 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

Device problems

  • Device Handling Problem1

Patient problems

  • Laceration(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 25, 2022Device Handling Problem; Device Handling Problem

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM SCOPE CT SYSTEM. ON (B)(6), 2022, IT WAS REPORTED THAT AN AN OPERATOR INJURED HIS FINGER ON THE ALUMINUM PLATE OF THE SEALING FLAP WHEN HE TRIED TO MOVE THE MCS (MONITOR CEILING SYSTEM). THE OPERATOR WAS TREATED AND RECEIVED ONE STITCH TO THE FINGER. WE ARE UNAWARE OF ANY FURTHER IMPACT TO THE STATE OF HEALTH OF THE OPERATOR. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Patient problems: Laceration(s)

    MAUDE report 15292433 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140912, K151749, K183548. 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)
  • Z-0920-2017 · Nov 22, 2016 · Terminated
    SOMATOM Scope Power, Computed tomography x-ray system
  • Z-0919-2017 · Nov 22, 2016 · Terminated
    SOMATOM Scope, Computed tomography x-ray system

Other System, x-ray, tomography, computed devices

All System, x-ray, tomography, computed devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.