The Health Sciences Authority (HSA) of the Singapore has posted a medical device safety alert concerning XR 6000 systems, manufactured by GE Healthcare.
The manufacturer has recently become aware of a potential safety issue with the horizontal tube arm of the system used on XR 6000 systems. There has been a reported incident of a horizontal tube arm falling from the system. A fall of a tube arm suspending the collimator and tube apparatus could result in a serious injury or death to a patient or operator. A minor injury has been reported as a result of this issue.
The manufacturer will correct the affected systems. The manufacturer recommends users not to use the XR 6000 System until they are corrected.
For details, please refer to the HSA's website:
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Medical_Devices/Product_Owners_FSN/2016/September.html
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 October 2016