# China NMPA Product Recall - Single-photon emission computed tomography system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systen-cleveland-inc/619f120b-1b16-46a0-b2e5-9fa030818719/
Source feed: China

> China NMPA product recall for Single-photon emission computed tomography system by Philips Medical Systen (Cleveland) Inc. published January 28, 2014. Recall level: . Philips Medical Systems (Cleveland), Inc., through its Chinese affiliate Philips (China) Investment 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems (Cleveland), Inc. is recalling its single-photon emission computed tomography (SPECT) systems.
- Company Name: Philips Medical Systen (Cleveland) Inc.
- Publication Date: 2014-01-28
- Product Name: Single-photon emission computed tomography system
- Recall Reason: Philips has received customer complaints regarding several software issues and will be addressing these issues in a newly released software version. Issue 1: When positioning for a non-circular trajectory acquisition relative to 180 degrees, the operator did not correctly position the second (bottom) detector, resulting in incorrect calculation of the patient's rotational trajectory. When acquisition begins, the detector starts moving into position, and the miscalculation causes the detector to touch the patient. Issue 2: In the separated state, when the gantry system moves to a 90-degree relative scanning position with the detectors, the patient or operator moves their hand or arm into the closing motion path of the two detectors, causing the detectors to touch the patient and operator. Issue 3: When the user manually positions the patient for examination and moves the bed board into the gantry opening, the bed board support bracket for the acquisition bed is higher than the imaging bed board, causing a pressure point or bed tilt if the bed board does not contact the bracket. This issue only occurs on the BrightView X or BrightView XCT systems. If the detector touches the patient or operator during gantry movement, it can cause serious injury to the patient or operator.
- Discovering Company: Shanghai Municipal Food and Drug Administration
- Manufacturing Company: Philips Medical Systen (Cleveland) Inc.
- Summary: Philips Medical Systems (Cleveland), Inc., through its Chinese affiliate Philips (China) Investment Co., Ltd., initiated a voluntary recall of its Single-Photon Emission Computed Tomography (SPECT) Systems, specifically BrightView X and BrightView XCT models. This recall was reported by the Shanghai Food and Drug Administration on January 14, 2014, and publicly noted by the National Medical Products Administration (NMPA) on January 28, 2014, stemming from Philips' internal report dated December 24, 2013. The regulatory framework for this recall is established under NMPA Index No. JGXX-2014-10009. The main violations concern critical software issues affecting 38 units imported into China. These issues include incorrect calculation of patient rotation trajectories during non-circular acquisitions, leading to potential detector-patient contact. Additionally, there are concerns about detectors making contact with patients or operators during gantry movement to a 90-degree scanning position if hands or arms are in the path. A third issue, specific to BrightView X/XCT, involves the bed board support bracket being misaligned, potentially causing pressure points or bed tilt. These deficiencies pose a risk of serious injury. The required actions involve Philips Healthcare issuing a field safety notice and a corrective action field change order (FCO). Field service engineers will implement on-site software updates to rectify these issues, with provincial and municipal food and drug administrations overseeing compliance.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systen-cleveland-inc/ed7d764b-6bff-4901-aefb-c49a08c8414f/