Class 2 Device Recall LifePak 500 Automatic external Defibrillator

• Date Initiated by Firm: March 20, 2020
• Date Posted: April 01, 2020
• Recall Status: Terminated on January 25, 2024
• Recall Number: Z-1633-2020
• Recall Event ID: 85194
• 510(K)Number: K052057 K012428 K983393 K955854
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s electrocardiographic (ECG) rhythm and indicates whether it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient.
• Code Information: All Lots
• Recalling Firm/ Manufacturer: Physio-Control, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: Stryker Customer Service; 425-867-4000
• Manufacturer Reason for Recall: Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment
• FDA Determined Cause: Device Design
• Action: The firm is planning on providing consignees on March 20, 2020 with an "Urgent Medical Device Safety Notice & Correction" letter concerning the LIFEPAK 500 AED. In addition to informing consignees about the recalled device, the recall notifications requested consignees take the following action: If you experience a "CONNECT ELECTRODES" voice prompt with the LIFEPAK 500, immediately remove and reinstall the electrodes to the device or replace the electrodes with your spare electrodes and check patient connection. If CONNECT ELECTRODES" voice prompt continues, immediately obtain a backup device and remove the LIFEPAK 500 from use. " Continue to perform the External Test Load Test per Maintenance section of the LIFEPAK 500 Operating Instructions and your local protocols as this test may identify this issue prior to being used on a patient. If during this test, a CONNECT ELECTRODES voice prompt message is received, immediately remove the device from service. " For any devices that are still within their expected life (meaning it has not been more than eight years since the original purchase of the new device from Physio-Control/Stryker or its authorized distributors), include the attached additional warnings and cautions as supplemental labeling for your device. " Review your attached affected device list and confirm if your device is still in service, transferred to a new location or is no longer in service. Please return the confirmation sheet by fax at 1-866-448-9567. If you have questions regarding the continued safe use of your products, please contact our Technical Support team at Stryker at 1 800 787 9537 and select option 2, 8:00 A.M. to 6:00 P.M. (Eastern time), Monday  Friday. More information from FDA regarding Legacy AED Systems can be accessed at https://www.fda.gov/medical-devices/cardiovascular-devices/automated-externaldefibrillators-aeds. If you have any questions about this matter contact Stryker at 1 800 787 9537, option
• Quantity in Commerce: 173,459 units
• Distribution: Worldwide distribution - US Nationwide distribution and countries of Afghanistan, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Barbados, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Congo, Cook Islands, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guam, Guatemala, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lithuania, Macedonia, the former Yugoslav Republic of, Madagascar, Malaysia, Mexico, Netherlands, New Caledonia, New Zealand, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Province of China, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Bolivarian Republic of, Vietnam, Virgin Islands, British, Virgin Islands, U.S., Zimbabwe.
• 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 = MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.; 510(K)s with Product Code = MKJ and Original Applicant = MEDTRONIC PHYSIO-CONTROL CORP.; 510(K)s with Product Code = MKJ and Original Applicant = PHYSIO-CONTROL CORP.