# FDA recall Z-1189-2021

> **Physio-Control, Inc.** · Class II · device recall initiated 2021-01-14.

## 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.

## Reason for recall

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

## 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, 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.

## Key facts

- **Recall number:** Z-1189-2021
- **Recalling firm:** Physio-Control, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-01-14
- **Report date:** 2021-03-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redmond, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1189-2021

## Citation

> AI Analytics. FDA recall Z-1189-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1189-2021. Source: US FDA. Licensed CC0.

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