Device Recall Philips Ingenuity TF PET/CT Imaging Systems 의 리콜

Recall

79696

Class 2

Z-1392-2018

2018-02-15

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163048

Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. this may prevent an acquisition from proceeding.

On February 15, 2018, the recalling firm notified customers of the recall via letter. The notice stated that to avoid the hazard of performing a rescan or reinjection, all users must be informed not to view studies or access data on the Addonics MSD while a patient is being scanned. If a user is attempting to view information stored on the Addonics MSD and the console appears to be unresponsive, reset power on the Addonics MSD or pull out and reconnect its USB cable. It is recommended that the Addonics USB Mass Storage Device be turned off when not being accessed, and powered on only when data transfer is needed. Following data transfer, the Addonics USB Mass Storage Device should be turned off. Customers were instructed to inform those who need to be aware within their organization or any organization wehre potentially affected devices have been transferred; transfer the notice to other affected organizations; and maintain the recall notice with their system Instructions For Use until the correction is made to the system. Customers were advised that Philips will be providing an updated Mass Storage Device that does not experience the same issue that will be provided at no additional cost to the customer. The Field Correction will be released in Q1 2018. Customers who need further information or support regarding the recall were directed to contact their local Philips representative. Customer Care Solutions Center: 1-800-722-9377.