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

ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.

FDA Recall Z-1325-06 · Posted 2006-08-03

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2005-10-31
Date Terminated2012-02-24
Product Quantity36

Reason for Recall

ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.

Firm Action

The firm initiated this recall on 10/31/2005, at which time a Field Action Note was issued to their Service Reps. The notice instructed the service personnel to upgrade all ABL800 analyzer units presently running with software version V5.21 to the new version V5.23, in order to correct this problem. The Service Personnel began conducting visits at each customer site on 10/31/2005.

Root Cause

Other

Distribution Pattern

Worldwide, including USA and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041874ABL800 FLEXRadiometer Medical Aps · 2004-10-08

Official Source

View FDA Recall →

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

↑