Recall Z-1453-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1453-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-15

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-02-15, terminated 2020-04-08. It names one FDA 510(k) clearance: K050297. Product: SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.. Reason: 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.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-02-15
Terminated: 2020-04-08
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K050297 — SOMATOM EMOTION 16Siemens Medical Solution, Inc. USA·cleared 2005-03-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SOMATOM Sensation 10 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.