Medical Device Recall: Z-0498-2020

FDA Recalls dataset · Firm: Philips North America, LLC · Status: Terminated

Recall Action Class: N/A Date Initiated: 2019-10-16 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0498-2020.

Recall Res Number
Z-0498-2020
Recalling Firm / Manufacturer
Philips North America, LLC
FEI Number
1218950
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2019-10-16
Date Posted
2019-11-19
Date Terminated
2023-11-29
Product Code
MKJ
Event Number
84115
Product Quantity
23,749 Units
Product Description HeartStart XL+ Defibrillator/Monitor, Model 861290
Reason for Recall The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user.
Action Details On October 16, 2019, Philips Healthcare issued Urgent Medical Device Correction notices to U.S. customers via certified mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Actions to be taken by the customer: 1) The device is safe to use and can remain in service if it does not exhibit any of these behaviors described in this Notice. 2) Continue to perform Shift Checks and Operational checks as recommended in the Instructions for Use (IFU) as this reduces the risk of a failure during use. 3) If you identify a device that exhibit any of these behaviors; please remove it from service and contact Philips to request service. Philips will contact you to arrange for repair of your unit once parts are available. Philips will install a replacement switch in affected devices at no charge to the customer. If you need further information or support concerning this notification, please contact your local Philips representative.
Distribution Pattern US Nationwide
Code Information / Serial Numbers All units manufactured prior to 1 May 2017.

Related Establishments / Registrations

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