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:
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:
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