Class 2 Device Recall LIFEPAK 20e defibrillator/monitor

• Date Initiated by Firm: April 16, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on March 29, 2011
• Recall Number: Z-1906-2008
• Recall Event ID: 47822
• 510(K)Number: K063119
• Product Classification: Automated External Defibrillator - Product Code LDD
• Product: Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.
• Code Information: LP20e Part Number: 3202487-104, 3202487-105, 3202488-053, 3202488-054; LP20e SN: 35664917, 35664919, 35664920, 35664921, 35664923, 35664924, 35664925, 35664926, 35664927, 35664928, 35664929, 35664931, 35664932, 35664933, 35664934, 35664936, 35664937, 35664938, 35664939, 35664941, 35664942, 35664943, 35664944, 35664945, 35664946, 35664947, 35664948, 35664949, 35664951, 35664952, 35664953, 35664954, 35664955, 35664956, 35664957, 35664958, 35664960, 35664961, 35664962, 35664963, 35664964, 35664965, 35664966, 35664968, 35664969, 35664970, 35664971, 35664973, 35664974, 35664975, 35664976, 35664977, 35664979, 35664981, 35664982, 35664983, 35664985, 35664986, 35664987, 35811291, 35811292, 35811293, 35811294, 35811295, 35811296, 35811298, 35811299, 35811300, 35811301, 35811302, 35811303, 35811304, 35811305, 35811306, 35811307, 35811308, 35811309, 35811310, 35811311, 35811312, 35811313, 35811315, 35811316, 35811317, 35811318, 35811319, 35811320, 35811321, 35811322, 35811323, 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• FEI Number: 3015876
• Recalling Firm/ Manufacturer: Physio Control, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: Todd Bandy; 425-867-4000 Ext. 4644
• Manufacturer Reason for Recall: The LIFEPAK 20e defibrillator / monitors with software versions 058 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning prior to anal
• FDA Determined Cause: Software design
• Action: On April 16, 2008, a letter was sent to the firms customers, via certified mail explaining the recall, giving product and software version information, request for customer to forward the notification to all sites and recommending the following: "Keep the defibrillator in service... Check the Auto Analyze Setup Option for each of your devices. If Auto Analyze is set to ON, change the setting to one of the other two choices: OFF or After First Shock... Follow the enclosed instructions to confirm or change the Auto Analyze Setup Option setting...If you update your defibrillator with new software, confirm the Auto Analyze Setup Option is set to OFF or After First Shock". Instructions for changing the auto analyze setup option for the LP 12 and LP20 were attached to the letter. There was no software issued in response to this action. Since LP20 customers may purchase a software program allowing them to update their defibrillator software, the letter recommends confirming Auto Analyze Setup Option is set to OFF or After First Shock if new software is installed . The default setting for the software update is Auto-Analyze ON. Contact Technical Support at 1-800-442-1142, option 5 - 6:00 a.m. to 4:00 p,m, (Pacific), Monday - Friday or visit www.Physio-Control-notices.com/sas if you have questions.
• Quantity in Commerce: 969 units
• Distribution: Product distributed nationwide and includes: 2 distributors, 157 direct accounts, 2,069 hospitals, 51 Department of Defense accounts, 58 miscellaneous government accounts, 3,295 first responders, 43 international accounts. International accounts are located in the following countries: ARGENTINA, AUSTRALIA, BARBADOS, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, COSTA RICA, DOMINICAN REPUBLIC, GERMANY, GUAM, GUATEMALA, GUYANA, HONG KONG, JAMAICA, JAPAN, MEXICO, NETHERLANDS ANTILLES, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PARAGUAY, PERU, PUERTO RICO, TRINIDAD, UNITED STATES, URUGUAY, and VIRGIN ISLANDS.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LDD