FrameArray Module HZ7 and Floorstand HZ5 의 안전성 경고

Safety alert

2011-10-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20111007.html

Urgent field safety notice: varian framearray module hz7 and floorstand hz5 medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning head ring posts used by both the framearray module (of the optical guidance platform) hz7 and floorstand hz5, where the head ring posts may be damaged due to excessive mechanical stress, resulting in possible failure during usage. this could result in the movement of the headring relative to the patient’s anatomy. according to the supplier, the affected devices have been distributed in hong kong. varian is sending a notification letter to affected users to remind them to inspect their head ring posts and verify that they are using the current design and that it is labeled with the part number 970.284. if the posts are not labeled 970.284, customers should discontinue use and contact varian service for replacement. varian will also arrange an inspection of all head ring posts and replace affected units.