LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Pro

FDA device recall Z-1633-2020 · posted 2020-04-01 · Terminated

Recall details

Recalling firm

Physio-Control, Inc.

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

Action taken

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

Root cause

Device Design

Status

Terminated

Product code

MKJ

Quantity affected

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, Berm

Date initiated

2020-03-20

Date posted

2020-04-01

Date terminated

2024-01-25

Location

Redmond, WA

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