FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: 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 of x-ray transmission data
- Recall number
- Z-2404-2019
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- 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 of x-ray transmission data
- Status
- Terminated
- Initiated
- 2019-07-31
- Posted
- not on file
- Terminated
- 2020-12-02
- Reason
- The injector holder could potentially fall off together with the injector and the storage box.
- Root cause
- Nonconforming Material/Component
- 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 .
- Quantity
- 12 units
- Distribution
- 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
- Lot, serial or model codes
- Serial Number 119145 119148 119119 119123 119133 119084 119087 119083 119143 119153 119122 119120
- 510(k) numbers
- ["K173632"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28