Z-1458-2018 Class II Terminated
FDA device recall Z-1458-2018 was initiated by Siemens Medical Solutions USA, Inc on Feb 15, 2018 and is designated Class II. 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 recall status is terminated (terminated Apr 8, 2020). Affected quantity: 1301.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- Feb 15, 2018
- Termination Date
- Apr 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1301
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
Distribution Pattern
USA (nationally) Distribution.
Code Information
8874427
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1458-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026