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 of x-ray transmission data
FDA Recall Z-2402-2019 · Posted None
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2019-07-31
Date Terminated2020-12-02
Product Quantity10 units
Reason for Recall
The injector holder could potentially fall off together with the injector and the storage box.
Firm Action
1. Take special care when rotating the injector and storage box horizontally
2. Your Siemens Healthineers service engineer will perform an on-site check to evaluate the stability of the injector arm.
3. If there is any problem with the injector arm, your Siemens Healthineers service engineer will replace the injector arm with an improved
intermediate version free of charge.
4. Please ensure all users of the affected products are aware.
5. Retain this notification in your product related records and place a copy in the medical device's instructions for use.
6. If you have distributed this product, identify your customers and notify them.
If you wish to request an earlier appointment or have additional questions, feel free to contact service organization at 1-800-888-7436 .
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide Distribution in the states FL KS WI NE MS OH TX NY LA IN IL OK MI GA NJ AK CT AL MD
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.