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 Cosmos. Radiological Image Processing. Model number 10018971

FDA Recall Z-0092-06 · Posted 2005-10-28

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2005-09-22
Date Terminated2006-08-23
Product Quantity64 units

Reason for Recall

reference lines appear above actual position

Firm Action

The company has issued a Customer Safety Advisory dated 9/22/05 via certified mail to the affected customers per Update Instructions CN038/05/S. The letter informs customers of the issue and also provides customer with instruction to avoid its occurrence.

Root Cause

Other

Distribution Pattern

The product was shipped to medical facilities in CA, CO, FL, IA, KS, LA, MD, MI, MO, NC, and PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042832SIENET COSMOS (VERSION V15A)Siemens AG Medical Solutions · 2004-10-28

Official Source

View FDA Recall →

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

↑