PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 4, 2019 Initiated: July 31, 2019 #Z-2404-2019

Product Description

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

Reason for Recall

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

Details

Units Affected
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
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 12 units.
Why was this product recalled?
The injector holder could potentially fall off together with the injector and the storage box.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 4, 2019. Severity: Moderate. Recall number: Z-2404-2019.