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FDA MEDWATCH ALERTS

April 18, 2014

FDA MedWatch - ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall

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FDA MedWatch Class I Recall 4 18 14

March 28, 2014

FDA Update on the Shortage of Normal Saline

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FDA Update on the Shortage of Normal Saline

March 18, 2014

FDA MedWatch - Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine

Summary:

Merit Medical Systems Custom Procedural Trays Kits Recall Particulates Found in Hospira Lidocaine

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LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure

Friday, July 02, 2010

Audience: Emergency Medicine, Cardiology, Risk Manager  

ISSUE: A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power". A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and no AC (line) power is available.

BACKGROUND: The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitor is designed for use by trained medical personnel in hospitals and clinic settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest. Approximately 42,943 devices were distributed worldwide between September 16, 2002 and September 27, 2007. These devices were manufactured from July 31, 2002 to September 19, 2007.

RECOMMENDATION: All affected power supplies will be updated. Customers are advised to keep the defibrillators in service and follow recommended daily Operator Checklist steps while service updates are scheduled. See Recall Notice for contact information.

Read the MedWatch safety alert, including a link to the FDA Class I Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm217980.htm

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