Device Recall Philips Healthcare Brilliance iCT 의 리콜

Recall

78879

Class 2

Z-0331-2018

2017-11-08

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160797

There is a possibility that screws holding an internal portion of the gantry (reaction ring) to the scanner s main bearing may come loose. if this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.

Philips Healthcare is informing consignees of this issue through a Customer Information Letter (CIL_FCO72800690). Philips Key Market representatives will distribute the letter internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Customers are notified that if they hear an unusual noise coming from the gantry, or scan halts, the Philips representative should be contacted as soon as possible. Philips will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost.