China NMPA Product Recall - Digital medical X-ray imaging system

Philips Medical (Suzhou) Co., Ltd. initiated a voluntary Level III recall of its Digital Medical X-ray Imaging Systems, specifically models DigitalDiagnost Power and DigitalDiagnost Pro. The recall was reported to the National Medical Products Administration (NMPA) on June 23, 2017, and publicly announced on June 26, 2017. This action affects 123 units manufactured or imported to China, with additional impact in Australia and New Zealand.

The primary issue stems from an internal firmware malfunction within the fixed flat panel detector (model Pixium 4343RC). This defect causes the detector to intermittently display as ready for image acquisition when it is not, potentially leading to the system failing to capture X-ray exposure images correctly. Crucially, no patient injuries have been reported as a result of this issue.

Philips' corrective action involves providing a complimentary software upgrade to resolve the firmware problem. Philips after-sales service engineers are tasked with contacting affected customers to arrange and implement this essential software installation, ensuring the medical devices operate safely and accurately in compliance with regulatory standards.