Spring Arm of surgical lights 의 안전성 경고

Safety alert

2012-10-31

2012-10-31

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121031.html

Medical device safety alert: stryker spring arm the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning spring arm of surgical lights, manufactured by stryker communications. the affected part numbers are as follows: 0682000112 spring arm, light 12-18kg 0682000211 flat panel spring arm, ondal suspension, 15-21kg 0682000212 flat panel spring arm, ondal susp., 12-18kg 0682000226 spring arm, 3.5-7kg, navigation 0682000228 spring arm, light 9-15kg 0682001062 pkg eds light suspension central axis 5p/fp 0682001270 9-pole spring arm, ac 2000, 15-21 kg 0682001274 5-pole spring arm ac 2000 15-21 kg 0682400034 flat panel spring arm, eds suspension, 15-21kg 0682400059 universal yoke spring arm retrofit kit 0682400059i universal yoke & spring arm retrofit kit, int 0682400151 low ceiling spring arm, 5p side mount 0682400152 low ceiling spring arm, 9p side mount 0682400169 5-pole spring arm ac 2000 9-15kg, cardinal 0682400207 standard spring arm with bearing, 5p 0682400208 standard spring arm with bearing, 9p 0682400365 flat panel spring arm with eha adapter bearing the manufacturer has identified that there is a low likelihood of incomplete engagement of the spring arm circlip during service or replacement of the spring arm. if the spring arm circlip is not fully seated, the spring arm could separate and fall along with the surgical lights, monitors or navigation cameras mounted to the end of the spring arm which may lead to serious injury. this action affects devices which were manufactured between june 2004 and february 2012 and is restricted to specific serial numbers only. to-date, there have been no serious injuries reported from the incomplete engagement of the spring arm circlip. furthermore, the manufacturer advised that: all affected users should inspect their inventory to see if the affected devices needed to be replaced. use of the spring arm should only be continued after confirmation that there is not a 10 mm gap or greater at the spring arm interface. the manufacturer will also visit the affected users to inspect, and if necessary, correct the spring arm circlip. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con195935 if you are in possession of the product, please contact your supplier for necessary actions. posted on 31 october 2012.