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SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cau...

FDA Device Recall #Z-1940-2018 — Class II — April 20, 2018

Recall Summary

Recall Number Z-1940-2018
Classification Class II — Moderate risk
Date Initiated April 20, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 33 units in US

Product Description

SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.

Reason for Recall

There is a potential for a software issue that may cause the need for necessary patient rescans.

Distribution Pattern

Worldwide Distribution: US (nationwide) including states of: AR, CA, CT, FL, GA, IL, IN, KS, KY, MO, ND, NY, OH, OK, SD, TN, TX, and VA; and countries of: Algeria, Australia, Austria, Bangladesh, Bolivia, Bosnia Herzog., Brazil, Cambodia, Chile, China, Columbia, Costa Rica, Germany, Greece, India, Indonesia, Italy, Japan, Kenya, Kuwait, Lithuania, Mauritius, Morocco, Nepal, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic Korea, Romania, Senegal, Singapore, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, Ukraine, and United Kingdom.

Lot / Code Information

Serial Numbers: 108052, 108053, 108054, 108055, 108056, 108057, 108058, 108059, 108060, 108061, 108062, 108063, 108064, 108065, 108066, 108067, 108068, 108069, 108070, 108071, 108072, 108073, 108074, 108075, 108076, 108077, 108078, 108079, 108080, 108081, 108082, 108083, 108084, 108085, 108086, 108087, 108088, 108089, 108090, 108091, 108092, 108093, 108094, 108095, 108096, 108097, 108098, 108099, 108100, 108101, 108102, 108103, 108104, 108105, 108106, 108107, 108108, 108109, 108110, 108111, 108112, 108113, 108114, 108115, 108116, 108117, 108118, 108119, 108120, 108121, 108122, 108123, 108124, 108125, 108126, 108127, 108128, 108129, 108130, 108131, 108132, 108133, 108134, 108135, 108136, 108137, 108138, 108139, 108140, 108141, 108142, 108143, 108145

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Z-1240-2026 Class II NAEOTOM Alpha Software applications: syngo.C... Dec 19, 2025
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Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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