HeartStart MRx recalled over fire hazard

Recall date

November 23, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Philips North America LLC recalls HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/…

Recall number

Z-0603-2019

FDA classification

Class II

Brand / firm

Philips North America LLC

Sold / distributed

U.S.: AZ, WA, PA, UT, NY, CO, MD, AR, TX, MO, MI, FL, VA, MA, GA, TN, NV, OH, CA, NH, KY, KS, OR, WI, NC, IL, LA, NJ, WV, AL, WY, MS Foreign (OUS): United Kingdom, Korea Rep, Singapore, Australia, Taiwan, Sri Lanka, Brazil, France, Switzerland, Germany, Austria, Spain, Italy, Trinidad and Tobago, E…

Why it was recalled

Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the Monitor/Defibrillator, the battery failure may go unnoticed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.