Recall Z-1189-2021
Physio-Control, Inc. · initiated January 14, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 year of age or older in cardiopulmonary arrest.
Codes / lots: Model Number 3321605-xxx, U.S. Device Part Numbers with Conforming Lids: CR2-2-001281, CR2-2-001279, CR2-2-001285, CR2-2-001278, CR2-2-001283, CR2-2-001280, CR2-2-001451, CR2-2-001452, CR2-2-000396, CR2-2-001457, Device Serial Numbers: 48603094 48784877 49025132 49091799 48741587 49077058 48764540 48764590 48601446 48603907 48609453 48652129 48652251 48858056 48981644 48722045 48726027 48726129 48726140 48726150 48693695 48694311 48698571 48698584 48952116 48953086 48554965 48817780 48825290 48849399 48899908 48899994 48900065 48900096 48901342 48901357 48901414 48901451 48902351 48977818 48978218 48981319 48981675 48981678 48981736 48981742 48981757 48981799 48982659 48982689 48982706 48982732 48982753 48982964 48983131 48983138 48986526 48999915 49001794 48677566 49000689 48474854 48825196 48744684 49025723 49078040 49084781 49084838 48784171 49076651 49077904 49077974 48999739 49001853 48598011 48597817 48598026 48598034 48598979 48599034 48599040 48599680 48599962 48600312 48600361 48600408 48600544 48600583 48876291 48785897 48720332 48764293 48780563 48781761 48785992 48742916 48784366 48814157 49086935 48523377 48857980 49085692 48734881 48782906 48809106 48809544 48813958…
Reason for recall
Due to complaints received regarding missing lid magnets which may result in premature battery depletion.
FDA-determined cause: Component design/selection
Action taken
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 automatically turn off within five minutes after being powered on if no patient is detected by the device. The customers were instructed to perform the actions in the notification letter to ensure safe and effective use of their devices. Actions are: 1. Inspect all devices to verify Green Readiness Indicator on device flashes every 6 seconds and the lid magnet is present according to the lid magnet inspection instructions at the end of this notification letter. If any devices are found with Readiness Indicator not flashing or the lid magnet missing, contact Customer Service at 1 800 787 9537 option 2 or by email at medtechsup@stryker.com. 2. Complete and return the Notification Acknowledgment Form attached to the notification letter by Fax at 1 866 448 9567 or by email RSRecall@stryker.com to confirm your receipt of the safety notification. 3. Review the Supplemental Instructions attached to the notification letter and retain the document as supplemental labeling for the device(s). 4. Continue to check device readiness at least monthly in accordance with the Operating Instructions, Maintaining a State of Readiness (pp. 77-78) and the instructions provided herein. Device readiness is indicated by: - All Devices: Green Readiness Indicator on device flashes every 6 seconds. If device is not ready, the Readiness Indicator will not flash. - Devices with Wireless Connectivity: In
Details
- Recall number
- Z-1189-2021
- Initiated
- January 14, 2021
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- 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. countries of: Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, Finland, France, Germany…
- Recalling firm
- Physio-Control, Inc., Redmond, WA