SOMATOM Definition AS-Computed tomography system Model 8098027
Reported: January 19, 2022 Initiated: November 19, 2021 #Z-0473-2022
Product Description
SOMATOM Definition AS-Computed tomography system Model 8098027
Reason for Recall
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 794 units
- Distribution
- US Nationwide distribution.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
SOMATOM Definition AS-Computed tomography system Model 8098027. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 794 units.
Why was this product recalled? ▼
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 19, 2022. Severity: Moderate. Recall number: Z-0473-2022.
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