Siemens SOMATOM go.Now Cl II

Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 6/62018
Class lI:

PRODUCT

SOMATOM Go.Now, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
Recall Number: Z-1939-2018

REASON
There is a potential for a software issue that may cause the need for necessary patient rescans.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 4/20/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4 units in US

DISTRIBUTION
Nationwide and Internationally

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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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.