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

AXIOM Sensis Programmable diagnostic computer, Model number 66 48 161

FDA Recall Z-0036-05 · Posted 2004-10-22

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeDQK
Date Initiated2004-07-09
Date Terminated2005-09-13
Product Quantity143 units

Reason for Recall

possible error calculating valve area with the AXIOM Sensis

Firm Action

The recalling firm has issued a Customer Advisory to the affected customers per Update Instructions AX053/04/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.

Root Cause

Other

Distribution Pattern

The product was shipped to one government account in KY and 87 medical facilities in AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, NE, NY, OH, OK, PA, SC, TX, VA, WA, and WV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020440NEWCORSiemens Medical Systems, Inc. · 2002-12-03

Official Source

View FDA Recall →

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

↑