Recall Z-2064-2020— Philips North America, LLC

Name: FDA recall Z-2064-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-10

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-04-10, terminated 2021-02-10. It names one FDA 510(k) clearance: K063375. Product: HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation.. Reason: Damaged ESD bags used for storing components in Processor PCA Replacement Kits.

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-04-10
Terminated: 2021-02-10
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K063375 — HEARTSTART MRX, MODELS M3535A OR M3536APhilips Medical Systems·cleared 2007-01-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation.

Reason for recall

Damaged ESD bags used for storing components in Processor PCA Replacement Kits

Data sourced from openFDA. This site is unofficial and independent of the FDA.