Device Recall Philips Healthcare 의 리콜

Recall

67857

Class 2

Z-1439-2014

2014-03-31

2014-04-09

Terminated

United States

2015-10-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126503

A component on the heartstart xl+ therapy board could malfunction potentially affecting the ability to deliver therapy.

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.