SOMATOM go.Now 11061610Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869051291), received between Oct 13, 2022 and Dec 12, 2022 — classified as 2 malfunctions.

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

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

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 16, 2026.

Recalls naming this device

1. Mar 7, 2022Open, Classified

   Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan

   Z-0962-2022 · Root cause: Software design · Recall details · FDA record ↗

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.

• MalfunctionDec 12, 2022Computer Software Problem; Computer Software Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT AND MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM GO.NOW CT SYSTEM. ON (B)(6) 2022, THE CT SCANNER CAUSED A DELAY IN DIAGNOSIS TO AN INTUBATED 50-YEAR-OLD FEMALE PATIENT. DURING POSITIONING OF THE PATIENT ON THE TABLE FOR A CHEST EXAM, THE CT SOFTWARE HUNG UP AND THE PATIENT WAS TAKEN OFF THE TABLE TO RESTART THE CT SYSTEM. AFTER THE PATIENT WAS REMOVED FROM THE EXAM TABLE, THE PATIENT COLLAPSED AND WAS IMMEDIATELY TRANSFERRED TO THE ICU. THE EXAMINATION WAS NOT REPEATED. IT WAS REPORTED TO SIEMENS ON (B)(6) 2022, THAT THE PATIENT HAD PASSED AWAY. CURRENTLY, THERE IS NO CORRELATION BETWEEN THE SYSTEM MALFUNCTION AND THE DEATH OF THE PATIENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 15959005 ↗
• MalfunctionOct 13, 2022Electrical /Electronic Property Problem; No Apparent Adverse Event; Electrical /Electronic Property Problem; No Apparent Adverse Event

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WITH THE SOMATOM GO.NOW CT SYSTEM. A SERVICE ENGINEER VISITED THE CUSTOMER TO CHECK THE CONDITION OF THE SITE AND WAS NOTIFIED THAT A FIRE HAD OCCURRED IN THE GANTRY ROOM ON (B)(6), 2022. ACCORDING TO AVAILABLE INFORMATION, THE ROOT CAUSE WAS A SHORT CIRCUIT ON THE CUSTOMER´S POWER CABLES. THE CUSTOMER REPORTED THAT THE FIRE WAS EXTINGUISHED BY THE FIRE DEPARTMENT. AS A RESULT OF THE FIRE, THE GANTRY COVERS WERE MELTED. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. AT THIS TIME, THERE IS NO INDICATION THAT THE CT DEVICE MAY HAVE CONTRIBUTED TO THIS EVENT. 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 15594326 ↗