SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the b...

FDA Device Recall #Z-1350-2016 — Class II — March 22, 2016

Recall Summary

Recall Number Z-1350-2016
Classification Class II — Moderate risk
Date Initiated March 22, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 1 CT system

Product Description

SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.

Reason for Recall

Siemens became aware that the front cover on some Siemens CT system was not properly welded. It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service. This could not happen during clinical operation. Therefore, there is no potential risk for the user or patient and the CT System has no risk for a malfunction during clinical operation

Distribution Pattern

Distributed to: Cincinnati, OH.

Lot / Code Information

Model Number: SOMATOM Definition AS-8098027 Serial # SOMATOM Definition AS- 95766

Other Recalls from Siemens Medical Solutions USA, Inc

Recall # Classification Product Date
Z-1175-2026 Class II Interventional Fluoroscopic X-Ray System: LUMIN... Dec 29, 2025
Z-1174-2026 Class II Interventional Fluoroscopic X-Ray System: LUMIN... Dec 29, 2025
Z-1241-2026 Class II NAEOTOM Alpha.Prime Software applications: s... Dec 19, 2025
Z-1240-2026 Class II NAEOTOM Alpha Software applications: syngo.C... Dec 19, 2025
Z-1239-2026 Class II SOMATOM X.ceed Software applications: syngo.... Dec 19, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

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.