# FDA recall Z-0816-2020

> **Physio-Control, Inc.** · Class II · device recall initiated 2019-12-20.

## Product

LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.

## 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.

## 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 Emirates, Qatar, Ireland, Greece, Spain, Poland, Saudi Arabia, Reunion, Israel, United Kingdom, Mexico, South Africa, China, Switzerland, Denmark, Cayman Islands, Finland, Norway, Austria, Japan, Belgium, Czech Republic, New Zealand, Slovenia, Republic of Korea, Oman, Egypt, French Guiana, Iceland, Portugal, Latvia, Lebanon, Chile, Kuwait, Bosnia and Herzegovina, Yemen, Eritrea, Martinique, New Caledonia, Kenya, Romania, Guinea, Luxembourg, Kazakhstan, Papua New Guinea, Brazil, Venezuela, Bolivarian Republic of, Trinidad and Tobago, Algeria, Turkey, Ukraine, Bahrain, Congo, the Democratic Republi

## Key facts

- **Recall number:** Z-0816-2020
- **Recalling firm:** Physio-Control, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-20
- **Report date:** 2020-01-22
- **Termination date:** 2022-10-04

- **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-0816-2020

## Citation

> AI Analytics. FDA recall Z-0816-2020. Retrieved 2026-06-22 from https://api.ai-analytics.org/recall/Z-0816-2020. Source: US FDA. Licensed CC0.

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