—#175727

Product

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 of x-ray transmission data

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K173632
Affected lot / code info: Serial Number 108183 108177 108176

Why it was recalled

The injector holder could potentially fall off together with the injector and the storage box.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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 .

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

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

Timeline

Recall initiated: 2019-07-31
Terminated: 2020-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175727. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.