Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1452-2018 — SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

U.S. FDA — Device Enforcement · United States · 2018-02-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1452-2018
Date of alert
2018-02-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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