Philips Healthcare is voluntarily recalling its ADAC Argus and ADAC Cirrus nuclear medicine gamma camera systems due to a potentially serious risk to patients.
The Argus and Cirrus product lines became part of Philips' portfolio when the company acquired ADAC Laboratories in December 2000. Philips' field safety notice to customers asks them to immediately stop using the gamma cameras and make sure that the devices remain idle.
Philips found a failure in the fork welding that could cause the detector assembly to detach and seriously injure or kill a patient, operator, or service personnel member if he or she is in the direct path.
There have been no reports of any incidents of a detector assembly coming apart and there have been no reports of serious injury or death as a result of this issue, according to Philips.
The field safety notice applies to all systems. Philips plans to replace the detector mounting arm and fork at no cost to the customer as part of its field change order, which will correct the problem with both systems and allow the devices to return to service after the repairs.
The gamma camera systems are labeled as ADAC Argus and ADAC Cirrus on the front of the detector.