Recall Z-0817-2020
Physio-Control, Inc. · initiated December 20, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Codes / lots: Serial numbers: 39432283 39432694 39432696 39432697 39432698 39432699 39432700 39432701 39432702 39432719 39432854 39432855 39432856 39432857 39432858 39432859 39432860 39432862 39432863 39432864 39432865 39432866 39432867 39432868 39432869 39432870 39432871 39432872 39432873 39432874 39432875 39432876 39432877 39432878 39432879 39432881 39432882 39432883 39432884 39432885 39432887 39432888 39432889 39432890 39432893 39432896 39432897 39432898 39432899 39432900 39432901 39435315 39436589 39451160 39451161 39451164 39451165 39451166 39451167 39451168 39451169 39451170 39451172 39451174 39451175 39451180 39451181 39451182 39451183 39451184 39451185 39451186 39451187 39451188 39451189 39451190 39451191 39451192 39451193 39451196 39451197 39451198 39451199 39451200 39451201 39451202 39451204 39451205 39451206 39451207 39451208 39451209 39451210 39451212 39451213 39451214 39451215 39451216 39451217 39451218 39451219 39451220 39451221 39451222 39451223 39451224 39451225 39451226 39451227 39451228 39451229 39451230 39451232 39451233 39451234 39451235 39451236 39451237 39451238 39451239 39451240 39451241 39451242 39451247 39451248 39451249 39451250 39451251 39451253 39451254 39451255…
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.
FDA-determined cause: Device Design
Action taken
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
Details
- Recall number
- Z-0817-2020
- Initiated
- December 20, 2019
- Terminated
- October 4, 2022
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 705
- Distribution
- 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…
- Recalling firm
- Physio-Control, Inc., Redmond, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0816-2020 Class II | LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an…Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result… | 12/20/2019Terminated |