China NMPA Product Recall - Positron emission tomography (PET) and X-ray computed tomography (CT) system

Siemens Healthineers initiated a voluntary Class II recall of its Positron Emission Tomography and X-ray Computed Tomography Systems, a measure publicly announced by the National Medical Products Administration (NMPA) on February 21, 2017. The core issue precipitating this recall was the potential for the laser positioning light window on these advanced medical imaging devices to become loose or detached. This defect raised concerns regarding the potential impact on the accuracy and safety of patient examinations.

Operating under the oversight of the NMPA, the recall was designated as Class II, indicating a situation where the use of or exposure to the affected product could lead to temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. The official notice, identified by index number JGXX-2017-10137, specified that particular models, specifications, and production batches of the systems were implicated, with comprehensive details available in the "Medical Device Recall Event Report Form." Siemens Healthineers' proactive decision to recall these products underscores its commitment to upholding product quality and patient safety standards, necessitating the identification and rectification of all impacted units to resolve the manufacturing discrepancy.