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Terminated

Evita 4 Continuous Ventilator

FDA Recall Z-0954-03 · Posted 2003-06-27

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2003-05-07
Date Terminated2006-01-20
Product Quantity806 units

Reason for Recall

software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.

Firm Action

The recalling firm issued recall letters to the accounts dated 5/7/03.

Root Cause

Other

Distribution Pattern

The product was shipped nationwide to distributor, hospitals and a physician. The product was also shipped to medical facilities and universities in Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010093NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474Drager Medizintechnik GmbH · 2001-06-14

Official Source

View FDA Recall →

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

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