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

Sienet Sky, picture archiving and communications system. Model number 8463163

FDA Recall Z-0071-2007 · Posted 2006-10-25

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2006-09-05
Date Terminated2008-09-17
Product Quantity1818 units total, for all three products

Reason for Recall

Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.

Firm Action

The recalling firm has issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions HS096/06/S and HS097/06/S. The letter, dated September 5, 2006, informs customers of this issue and provides recommendations to avoid its occurrence.

Root Cause

Other

Distribution Pattern

The product was shipped to medical facilities nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935694SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADESiemens Medical Solutions USA, Inc. · 1994-03-07

Official Source

View FDA Recall →

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

↑