Recall – Siemens Artis zee floor MN; Cl II

Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 7/4/2018
Class lI:

PRODUCT

Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures.
Recall Number: Z-2312-2018

REASON
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system..

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 5/1/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1

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

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