SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Reported: May 8, 2019 Initiated: February 14, 2019 #Z-1244-2019
Product Description
SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Reason for Recall
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 53 total units distributed in U.S.
- Distribution
- US Nationwide Distribution
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems 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: 53 total units distributed in U.S..
Why was this product recalled? ▼
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2019. Severity: Moderate. Recall number: Z-1244-2019.
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