SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Reported: May 9, 2018 Initiated: February 15, 2018 #Z-1458-2018
Product Description
SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Reason for Recall
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 1301
- Distribution
- USA (nationally) Distribution.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 1301.
Why was this product recalled? ▼
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 9, 2018. Severity: Moderate. Recall number: Z-1458-2018.
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