syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
Reported: September 11, 2019 Initiated: July 25, 2019 #Z-2440-2019
Product Description
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
Reason for Recall
SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 2867 units worldwide (OUS); 1464 units US
- Distribution
- Nationwide Foreign:
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 2867 units worldwide (OUS); 1464 units US.
Why was this product recalled? ▼
SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 11, 2019. Severity: Moderate. Recall number: Z-2440-2019.
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