Recalls / —

—#126503

Product

Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.

FDA product code

MKJ — Automated External Defibrillators (Non-Wearable)

Device class

Class 3

Medical specialty

Cardiovascular

510(k) numbers

K110825

Affected lot / code info

Serial Numbers: USN1307680 USD1309181 USD1308456 USD1309182 USD1309167 USD1309184 USD1309168 USD1309194 USD1309180 USD1309195 USD1309196 USD1309274 USD1309197 USD1309286 USD1309227 USD1309301 USD1309264 US11409686 USD1309269

Why it was recalled

A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy

Root cause (FDA determination)

Reprocessing Controls

Action the firm took

Philips Healthcare issued an Urgent-Medical Device Correction letter dated March 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice is intended to inform you about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer/user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem. A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy. Please see the attached Field Safety Notice that provides information on how to identify affected devices and instructions on actions to be taken. Please follow the ACTION TO BE TAKEN BY CUSTOMER / USER section of the notice. To correct this issue Philips will provide a replacement therapy board to customers with affected units free of charge. This voluntary correction has been reported to the appropriate regulatory agencies. If you need any further information or support concerning this issue, please contact your local Philips representative at Philips representative contact details to be completed by the KM / country. Philips apologizes for any inconveniences caused by this problem. Further questions please call (978) 687-1501.

Recalling firm

Firm

Philips Medical Systems, Inc.

Address

3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern

Worldwide Distribution - US Distribution including the states of IN and WA., and the countries of : CHINA FRANCE GERMANY ITALY MALAYSIA PANAMA SAUDI ARABIA TURKEY and UNITED KINGDOM.

Timeline

Recall initiated

2014-03-31

Posted by FDA

2014-04-09

Terminated

2015-10-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #126503. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.