SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Reported: November 27, 2019 Initiated: September 24, 2019 #Z-0265-2020
Product Description
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Reason for Recall
SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 14 US
- Distribution
- US in the states of: GA, IN, MO, MS, NJ, OH, PA
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 14 US.
Why was this product recalled? ▼
SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2019. Severity: Moderate. Recall number: Z-0265-2020.
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