Philips Medical Systems, Inc. recalls Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A

Recall date

November 19, 2014

Source

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

Recall number

Z-0204-2016

FDA classification

Class II

Brand / firm

Philips Medical Systems, Inc.

Sold / distributed

Worldwide Distribution - USA (nationwide), Australia, Austria, Bahrain, Belgium, Brunei Darussalam, Canada, China, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Republic of Korea, Libyan Arab Jamahiriya, Lithuania, Mexico, Namibia, Netherlands, Palestine, Phi…

Why it was recalled

1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication

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

What was recalled

Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A