Class 2 Device Recall LIFEPAK 12 Defibrillator/Monitor

• Date Initiated by Firm: January 16, 2017
• Create Date: February 07, 2017
• Recall Status: Terminated on September 11, 2018
• Recall Number: Z-1143-2017
• Recall Event ID: 76162
• 510(K)Number: K102972
• Product Classification: Cardiac Defibrillator/Monitor - Product Code MKJ
• Product: LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. ; ; The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). ; ; The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
• Code Information: LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544. SERIAL NUMBERS OF DEVICES: 32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.
• Recalling Firm/ Manufacturer: Physio-Control, Inc.; 11811 Willows Rd NE; Redmond WA 98052-2003
• For Additional Information Contact: Customer Support; 800-442-1142 Ext. 7
• Manufacturer Reason for Recall: The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
• FDA Determined Cause: Process control
• Action: Physio Control sent the Urgent Medical Device Correction LIFEPAK 15 Monitor/ Defibrillator and LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 (EtCO2) option letter, dated January 2017, and confirmation sheets to consignees on January 16, 2017. Physio-Control is contacting customers with affected devices to schedule the correction of their device(s), which will include replacing the EtCO2 module. Required Customer Actions: 1. Please forward this information to all affected sites, trainers and users that may have affected LIFEPAK 12 or LIFEPAK 15 device(s). 2. Consignees should follow the instructions on the Confirmation Sheet for each serial number listed in their possession. Promptly return the completed Confirmation Sheet to Physio-Control. 3. If consignees experience the XXX after power-up or during device operation, please contact Physio-Control to arrange for servicing of their device. Consignees should return completed confirmation sheet: -By fax to: 1-866-448-9567 -By email to: rsrecall@physio-control.com -Or by mail to: Physio-Control, Inc. P.O. Box 97006, Dept. 15N Redmond, WA, 98073-9706 Consignees with questions can call the firm at 1-800-442-1142, option 7, 6:00 A.M. to 4:00 P.M. (Pacific), Monday  Friday.
• Quantity in Commerce: 7 units in the US and 13 modules worldwide (5 international; and 8 owned by Physio)
• Distribution: Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.
• 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 = MKJ and Original Applicant = PHYSIO-CONTROL, INC.