China NMPA Product Recall - Single-photon emission and X-ray computed tomography (SPECT) system; Single-photon emission computed tomography (SPECT) scanning system; Forte gamma camera system; Single-photon emission and X-ray computed tomography (SPECT) imaging system

Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall for several models of its Single-Photon Emission Tomography (SPECT) systems and Forte Gamma Camera systems. This action was reported by the National Medical Products Administration (NMPA) on January 28, 2021, following Philips’ internal recall document CLE18-028. The primary issue stems from a software malfunction within the WorkSpace thyroid analysis application. When using the JETStream component and the transfer coefficient (TCO) parameter, this application may calculate thyroid uptake values that are lower than the patient's actual uptake. This critical discrepancy could potentially lead to inaccurate diagnostic assessments for patients undergoing thyroid scans. While Philips (China) has confirmed no related injuries or deaths worldwide to date, the company is proactively addressing this potential safety concern to maintain the integrity of diagnostic results. The recall encompasses specific devices identified by various CFDA Import Medical Device Registration Numbers. Philips (China) is implementing this recall as a crucial corrective action under NMPA’s regulatory framework, ensuring the rectification of the software defect to prevent any potential misdiagnosis and uphold product reliability and patient well-being.