SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Reported: May 23, 2018 Initiated: November 8, 2017 #Z-1745-2018
Product Description
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Reason for Recall
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 1385
- Distribution
- Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 1385.
Why was this product recalled? ▼
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 23, 2018. Severity: Moderate. Recall number: Z-1745-2018.
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