Terminated

LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.

FDA Recall Z-0816-2020 · Posted None

Recalling FirmPhysio-Control, Inc.

Recall StatusTerminated

Product CodeMKJ

Date Initiated2019-12-20

Date Terminated2022-10-04

Product Quantity29952

Reason for Recall

Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.

Firm Action

On 12/20/19, Urgent Medical Device Safety Notice & Correction Action Required notifications were mailed to customers informing them to review the affected device list (www.strykeremergencycare.com/fa282response). Upon confirmation of device status, field service personnel will contact you to arrange for the correction of the device, which will include a replacement of the affected keypad. The devices subject to this correction are planned to be serviced by June 30, 2021. You may continue to use affected Monitors/Defibrillators according to the Operating Instructions until the correction can be completed. The other functions of the device are not affected by this issue. Routine testing of your device may detect this fault condition. If the device fails the daily check prior to use a "disarming" message will be displayed, and the service light will be illuminated. Contact Technical Support immediately to report the incident. If the issue occurs during patient use, a "disarming" message will be displayed, and the service light will illuminate. Immediately repeat your charge and shock cycle according to the Operating Instructions. If you receive the "disarming" message again, utilize hard paddles or a backup device. Remove the device from service and contact Technical Support immediately to report the incident. Each customer received an impacted device list listing affected serial numbers. Customers were asked to go to https://www.strykeremergencycare.com/productnotices to provide verification of the status of affected devices and to acknowledge the corrective action. If you have questions regarding the continued safe use of your products, please contact our Technical Support team at 1-800-787-9537, 8:00 A.M. to 6:00 P.M. (EST), and select option 2. Service providers were provided with instructions pertaining to the replacement of affected keypads. Service providers outside of the U.S. were provided with kit serial numbers and asked to identify the de

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - U.S Nationwide: GA, PA, IN, CA, KY, FL, AZ, WA, NC, MD, TX, CO, VT, MI, MA, TN, OH, CT, NY, MO, VA, IA, MN, LA, WV, MT, IL, AR, UT, NJ, OK, NV, NH, MS, NM, WI, OR, ID, SC, NE, AK, SD, AL, WY, RI, KS, ME, DE, ND, DC, HI, PR O.U.S. (Foreign): Germany, Netherlands, Hong Kong, Costa Rica, Canada, Singapore, Australia, France, Croatia, Italy , Sweden, Hungary,United Arab Emirates, Qatar, Ireland, Greece, Spain, Poland, Saudi Arabia, Reunion, Israel, United Kingdom, Mexico, South Africa, China, Switzerland, Denmark, Cayman Islands, Finland, Norway, Austria, Japan, Belgium, Czech Republic, New Zealand, Slovenia, Republic of Korea, Oman, Egypt, French Guiana, Iceland, Portugal, Latvia, Lebanon, Chile, Kuwait, Bosnia and Herzegovina, Yemen, Eritrea, Martinique, New Caledonia, Kenya, Romania, Guinea, Luxembourg, Kazakhstan, Papua New Guinea, Brazil, Venezuela, Bolivarian Republic of, Trinidad and Tobago, Algeria, Turkey, Ukraine, Bahrain, Congo, the Democratic Republic of the, Nigeria, Lao People's Democratic Republic, Russian Federation, Cyprus, Pakistan, Faroe Islands, Gabon,Libya, Thailand, Indonesia, Lithuania, Georgia, Malta, Macedonia, the former Yugoslav Republic of, Suriname, San Marino, Morocco, Guam, Taiwan, Province of China, Malaysia,Serbia, Brunei Darussalam, Argentina, Virgin Islands, U.S., Barbados, Mali, Iraq, Azerbaijan, Botswana, Kosovo, Cambodia, Cura¿ao, Ecuador, Aruba

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.