Device Recall Brilliance 64 and Ingenuity CT 의 리콜

Recall

61363

Class 2

Z-1285-2012

2012-02-17

2012-03-23

Terminated

United States

2013-02-22

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107919

A number of non-conformances were identified during internal and external validation testing of the brilliance 64 and ingenuity ct systems with software version beta 3 (version 4.0.0.Xx368).

Philips Healthcare sent an Urgent Medical Device Correction letter dated February 17, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of the contents in the communication. Customers were asked to retain a copy of the communication with the equipment instruction for Use. For further information or support concerning this issue, customers should contact their local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center at 1-800-722-9377, option 5. For questions regarding this recall call 440-483-7000.