Device Recall Precedence 의 리콜

Recall

57589

Class 2

Z-1550-2011

2010-12-28

2011-03-04

Terminated

United States

2012-04-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96729

Philips healthcare nuclear medicine determined that the detector arm assembly could be compromised.

Urgent - Medical Device Correction notifications were sent to all domestic consignees on December 28, 2010 via Federal Express. The letter identified the affected products, the reason for the recall, the hazard involved, and actions to be taken by the customer/user. Customers have been instructed to immediately stop using the system and contact a Philips service representative for an immediate inspection if one of the listed reasons apply. Customers were also instructed to follow the instructions in the system's Instructions For Use to avoid a collision or force on the detector. The firm's service will contact customers to arrange a time for Philips to conduct an inspection and to conduct the appropriate field safety correction. The letter should be placed in customers' Instructions For use. Notices to international consignees will be sent as soon as translation is complete. If customers need further information or support concerning this issue, they should contact their local Philips representative.