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Open, Classified

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.

FDA Recall Z-1189-2021 · Posted None

Recalling FirmPhysio-Control, Inc.
Recall StatusOpen, Classified
Product CodeMKJ
Date Initiated2021-01-14
Product Quantity89,763 units

Reason for Recall

Due to complaints received regarding missing lid magnets which may result in premature battery depletion.

Firm 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 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 [email protected]. 2. Complete and return the Notification Acknowledgment Form attached to the notification letter by Fax at 1 866 448 9567 or by email [email protected] 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

Root Cause

Component design/selection

Distribution Pattern

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, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Qatar, Saint Barth¿lemy, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

Official Source

View FDA Recall →

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

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