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
