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Terminated

Evita XL Critical Care Ventilator. Continuous (Respirator)

FDA Recall Z-2327-2008 · Posted 2008-09-20

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2008-07-02
Date Terminated2009-09-01
Product Quantity83 units

Reason for Recall

audible power failure alarm was not enunciated at the required volume

Firm Action

The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/2/08 informing the consignees of the problem and the need to have the circuit board replaced.

Root Cause

Nonconforming Material/Component

Distribution Pattern

The products were shipped to medical facilities in AZ, CA, CO, FL, GA, IL, KY, MA, MI, MS, NJ, NY, PA, TN, TX, UT and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051263EVITAXL WITH OPTION SMARTCAREDrager Medical AG & Co. Kgaa · 2005-07-12

Official Source

View FDA Recall →

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

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