Feb

2012

Cl ll Siemens syngo.plaza VA20A Server Farm setup

Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 2/1/12
Class ll:

PRODUCT
Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457. Recall # Z-0827-2012

REASON
The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to a RIS. Sporadically it can happen that certain Patient IDs in the database are deleted and sent to NULL. This can cause incorrect merging with patients that already had a NULL Patient ID.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter in May 2011.
Manufacturer: Siemens AG, Medical Solutions, Business Unit XP, Erlangen, Germany. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3

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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Cl ll Siemens syngo.plaza VA20A Server Farm setup

Amy Sellers

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