Medical device manufacturer, Medtronic, has issued a field safety notice (FSN) concerning certain Styker's Berchtold F-generation LED lights with affected model numbers of F528 (with a serial number smaller than 831800001526) and F628 (with a serial number smaller than 831710002819).
There is the potential for electromagnetic interference (EMI) between Medtronic's StealthStation AxiEM or Fusion EM technology and the abovementioned models of Styker's Berchtold F-generation LED lights.
When the lights are positioned according to Berchtold's Instructions for Use – at a distance at least one meter from the patient – there is no interference. When the lights are positioned closer to the patient, the resulting EMI causes the StealthStation AxiEM or Fusion EM system to cease tracking and display "red status", which prevents navigation until the EMI is removed. The testing confirmed that the StealthStation AxiEM/Fusion System meets specification.
If users have the devices with one of the affected serial number ranges above, they should consider limiting use of the AxiEM or Fusion EM system to rooms that do not have these lights installed. If no alternative room is available, customers are reminded to ensure use of the lights according to the Berchtold Instruction for Use, maintaining a light head position at least one meter from the surgical site.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 November 2014