Recall Z-1189-2021 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1
| Date | Jan 14, 2021 |
| Status | Open, Classified |
| Reason | Due to complaints received regarding missing lid magnets which may result in premature battery depletion. |
| Root cause | Component design/selection |
| Action | On 01/26/2021, the firm, Stryker, sent "URGENT MEDICAL DEVICE SAFETY NOTICE AND CORRECTION" Letters to its customers and distributors via a courier service. The letter describes the product, problem and actions to be taken. Customers were informed that the lid magnet is the primary means by which the device will turn on and off when the lid is opened or closed. If the lid magnet is missing, the device battery can deplete prematurely, even if the device is not powered on. When the magnet is missing, the user can still use the power button to turn the device on and off. The device will automatic |
| Quantity | 89,763 units |
| Distribution | Worldwide Distribution to U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI , SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV and WY O.U.S. countr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.