Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It operates in a manual or semi-automatic defibrillation mode and is offered with optional monitoring functions including Non-Invasive Blood Pressure (NIBP). When clinically indicated the LIFEPAK 15 allows the operator to deliver a brief, high energy, external shock through the chest to a patient's heart.
FDA Recall Z-2110-2009 · Posted 2009-09-18
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Recalling FirmPhysio Control, Inc.
Recall StatusTerminated
Product CodeDXN
Date Initiated2009-08-12
Date Terminated2012-08-10
Product Quantity445 devices worldwide
Reason for Recall
Some LIFEPAK 15 Monitor/Defibrillators have a Non-Invasive Blood Pressure (NIBP) module that was supplied by CAS Medical Systems, Branford, Connecticut who is recalling the modules. The NIBP modules may be susceptible to sudden changes in cuff pressure. Sudden changes in cuff pressure may possibly be caused by bumping or squeezing the
cuff. In some instances this may result in a screen display
Firm Action
The firm notified customers by letter dated August 2009. Customers will have the Noninvasive Blood Pressure (NIBP) module replaced. If additional questions about the notification, contact Technical Support by calling 1-800-442-1142, option 5, Monday-Friday 6:00 a.m. to 4:00 p.m. (Pacific Standard Time).
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Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- US, AUSTRALIA, GERMANY and NETHERLANDS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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