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

AUDICOR 200 D Inovise Part Number 30047 (console part number 20158).

FDA Recall Z-0565-06 · Posted 2006-03-03

Recalling FirmInovise Medical, Inc.
Recall StatusTerminated
Product CodeDPS
Date Initiated2003-01-12
Date Terminated2006-07-24
Product Quantity28 units

Reason for Recall

Use of the AUDICOR 200 D in-line with a defibrillator/monitor resulted in interruption of pacing therapy to a patient when the AUDICOR 200 D stopped working due to low battery power.

Firm Action

On January 12, 2006, 2 of 3 customers were notified by telephone, with follow-up email. All three customers were visited by the firm on January 16-17, 2006. Customers were instucted to not use the device in-line with a defibrillator/monitor.

Root Cause

Other

Distribution Pattern

Product distributed to three EMS/Fire Departments located in Florida and Washington

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043074LIBERTY SYSTEMInovise Medical, Inc. · 2005-02-22

Official Source

View FDA Recall →

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

↑