Recall Z-2053-2020— Philips North America, LLC

Name: FDA recall Z-2053-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-13

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-04-13, terminated 2021-04-07. It names one FDA 510(k) clearance: K001725. Product: Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital 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. It must be used by or on the order of a physician.. Reason: The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-04-13
Terminated: 2021-04-07
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K001725 — HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735AAgilent Technologies, Inc.·cleared 2000-09-08

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

Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital 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. It must be used by or on the order of a physician.

Reason for recall

The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.

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