RSS
Логотип
Баннер в шапке 1
Баннер в шапке 2

GE Millennium (gamma camera)

Product
Developers: GE Healthcare
Branches: Pharmaceutics, medicine, health care
Technology: MPT

2018: A withdrawal of the rejected equipment

On November 6, 2018 the GE Healthcare company completed check of all the gamma cameras in the USA. Unplanned large-scale inspection became result of the incident which took place in September, 2018. According to data of the company, the upper detector of the gamma camera came off a support and fell to the lower detector which was under it.

As a result of a lead of the detector any patient did not suffer, however this incident induced GE Healthcare to recall all gamma cameras of lines Millennium Millennium, Millennium MC and Millennium MyoSight. State control bodies of the USA appropriated to an incident the first hazard class as having the most serious effects and specifying that use of this type of devices "can lead to serious injuries or death".

Gamma camera GE Millennium

Gamma cameras which GE Healthcare had to be recalled from the market were manufactured during the period from January 1, 1997 to July 1, 2012 and extended from January 1, 1997 to September 1, 2018 on permission of state control bodies of the USA. As a result of an incident GE Healthcare asked clients to refuse use of 996 devices.

In the address to clients of September 14, 2018 GE Healthcare recommended to suspend use of gamma cameras of three models which an incident concerned until the company performs complete and free inspection of all systems. GE Healthcare defined that the lack of the mechanical stopper intended for restriction of the movement of the detector during the normal work became a cause of defect of the detector. Besides, GE Healthcare and regulating authorities revealed that the additional stopper was present, but did not work properly.

GE Healthcare reported that it graduated from inspection of all systems and did not reveal any problems. Use of devices was resumed.[1]

Notes