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

Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.

FDA Recall Z-0301-2007 · Posted 2006-12-19

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeMHX
Date Initiated2006-11-17
Date Terminated2008-11-19
Product Quantity23,345 units - 4336 US

Reason for Recall

Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.

Firm Action

The recaling firm issued a recall letter to the US customers 11/17/2006 via certified mail. An authorized service representative will inspect each potentially affected unit. If a unit is found to have an affected docking station, the unit will be repaired or replaced free or charge. Notification to international customers will occur through the international subsidiaries.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060039INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONSDraeger Medical Systems, Inc. · 2006-04-12

Official Source

View FDA Recall →

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

↑