Reader provides information on product safety alert for CT scanners
To the Editor:
With respect to the recent controversy surrounding the choice of CT scanner for the Kincardine hospital, readers might be interested in the following information regarding these very expensive devices.
Here's some information about the CT-Edge and CT-Drive scanners. It looks as if both systems have had a safety recall notice since Nov. 20, 2019.
Click on the following link for the Canadian version of this safety recall notice:
healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74429r-eng.php#reason-motif
Click on the following link for the American version:
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183480
The information below has been copied from the website at:
www.softwarecpr.com/2019/11/recall-ct-scanner-software-issue-leads-to-system-crash/
Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 11/20/2019
Class II
PRODUCT
Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20
Recall Number: Z-0406-2020
David Whiting
Kincardine
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