Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system

FDA Recall Z-1127-2012 · Posted 2012-02-29

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-01-20
Date Terminated2012-09-29
Product Quantity7

Reason for Recall

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 deleti

Firm Action

Siemens sent a Customer Safety Advisory Notice letter dated January 20, 2012 to all affected consignees. The letter identified the affected product, problem, steps to take to avoid this issue, and actions to be taken. Customers were instructed to contact their local Siemens Service to plan for their software update and ensure that this safety advisory is placed in the system's instruction for use.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution (USA) - CA, FL, GA, MO, NY and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093612SYNGO.PLAZASiemens AG Medical Solutions · 2010-03-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑