SOMATOM go.All 11061638Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869151588), received between Jul 23, 2020 and Jul 23, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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

17 other recalls cover devices cleared under the same FDA submission (K173632); 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 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO SIEMENS THAT DURING A FOLLOW-UP APPLICATION TRAINING THE SIEMENS APPLICATION SPECIALIST WAS MADE AWARE OF AN EVENT AT THE FACILITY THAT OCCURRED AT THE FACILITY. IT WAS REPORTED THAT AN (B)(6) INFANT HAD TO BE RE-SCANNED ON THE SOMATOM GO.ALL SYSTEM. THE SYSTEM HAD BEEN DELIVERED TO THE FACILITY DURING MAY 2020. UNFORTUNATELY, THE ISSUE WAS NOT REPRODUCIBLE. THE CUSTOMER WAS ALSO UNABLE TO CLARIFY WHICH WORKFLOW THEY USED, AS IT WAS A STRESSFUL SITUATION WITH MANY PHYSICIANS AND OTHER PERSONS INVOLVED. THE CUSTOMER STATED THE SYSTEM WAS NOT ABLE TO SCAN AFTER THE FIRST TOPOGRAM (LOW DOSE OVERVIEW SCAN). THEREFORE, THE LEAD SHIELDING WAS REMOVED, AND THE INFANT PATIENT RECEIVED ANOTHER TOPOGRAM (TYPICAL X-RAY DOSE OF LESS THAN 1MSV). BESIDE THE LOW-LEVEL ADDITIONAL X-RAY DOSE, NO OTHER INJURY TO THE INFANT PATIENT WAS REPORTED TO SIEMENS. THE USER WAS TRAINED HOW TO USE THE SYSTEM WITH PATIENTS WEARING RADIATION PROTECTION SHIELDING. THIS REPORT HAS BEEN FILED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Code Available

  MAUDE report 10316359 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173632. One submission often covers many models, so check the product and lot details in each record.

• Z-1253-2021 · Mar 3, 2021 · Terminated
  Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 110616
• Z-0265-2020 · Sep 24, 2019 · Terminated
  SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
• Z-2404-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction
• Z-2401-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction
• Z-2402-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction
• Z-2400-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction o
• Z-2405-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction
• Z-2399-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer rec
• Z-2403-2019 · Jul 31, 2019 · Terminated
  SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction
• Z-1921-2019 · Jun 4, 2019 · Terminated
  SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process c
• Z-1920-2019 · Jun 4, 2019 · Terminated
  SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process c
• Z-1919-2019 · Jun 4, 2019 · Terminated
  SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cr
• Z-1922-2019 · Jun 4, 2019 · Terminated
  SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process c
• Z-1918-2019 · May 28, 2019 · Terminated
  SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cro
• Z-1917-2019 · May 28, 2019 · Terminated
  SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cr

…and 2 more.