Medical device manufacturer, Philips Medical Systems, has issued a medical device safety alert concerning all units of DigitalDiagnost, Essenta DR, Essenta DR compact, BuckyDiagnost, EasyDiagnost Eleva and TraumaDiagnost using the 5-Field Amplimat chamber, serial numbers from 11320067 to 11321695 and from 11322000 to 11322231.
If direct radiation hits an Amplimat field (selected or unselected), the Amplimat signal amplifier can enter an undefined state, and one or more of the following Automated Exposure Control (AEC) exposures (using the Amplimat) can be overexposed. As a result, the generator does not switch off the exposure when the intended dose is reached; however, it does switch off when the backup shutoff condition is reached. If the pre-programmed APR/EPX settings are used, the overexposure is small and the image generated is usable for diagnostic purposes. If the operator overrides the pre-programmed settings, the image generated may be unusable (i.e. not correctly exposed) and more radiation may be administered than intended.
The manufacturer advised the affected users to take the following actions:
The manufacturer will instruct Field Service Engineer to remove the affected Amplimat chamber for devices with serial numbers from 11320067 to 11321695 and from 11322000 to 11322231, and install a new one.
According to the local supplier, the affected devices were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 19 October 2012