08

Mar

2012

Cl ll Siemens syngo.plaza

0

Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 3/7/12
Class ll:

PRODUCT
Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system. Model number 10592457. Recall # Z-1127-2012

REASON
There is a potential malfunction when using syngo.plaza VA20B_HF04 with USB dongle and archive license. In syngo.plaza VA20B_HF04, there is a scenario where data in Short-Term Storage (STS) could reaming unprotected and not archived. this can happen when an archive server with a USB dongle-based license is enabled with auto archiving. If the disk fill level is reached which triggers auto deletion, this could result in deletion of unarchived data.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated January 20, 2012.
Manufacturer: Siemens AG, Medical Solutions, Business Unit XP, Erlangen, Germany. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7 units

DISTRIBUTION
Nationwide

About the author

Amy Sellers

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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