25
Apr
2018

Siemens PRIMUS HI : Cl II

0

Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 4/25/2018
Class lI:

PRODUCT

PRIMUS HI, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer
Recall Number: Z-1402-2018

REASON
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 2/14/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
18

DISTRIBUTION
Nationwide, PR and Nassau

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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