# China NMPA Product Recall - Single-photon emission and X-ray computed tomography (SPECT) system; Single-photon emission computed tomography (SPECT) scanning system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/98404313-a798-4531-a5d4-ad2e5e5a50dd/
Source feed: China

> China NMPA product recall for Single-photon emission and X-ray computed tomography (SPECT) system; Single-photon emission computed tomography (SPECT) scanning system by Philips (China) Investment Co., Ltd. published June 17, 2019. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its Single-Photon Emis

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling single-photon emission and X-ray computed tomography (SPECT) systems and single-photon emission computed tomography (SPECT) scanning systems.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2019-06-17
- Product Name: Single-photon emission and X-ray computed tomography (SPECT) system; Single-photon emission computed tomography (SPECT) scanning system
- Recall Level: Level 2 Recall
- Recall Reason: A problem has emerged with the manual controller of BrightView series cameras, causing spontaneous or continuous motion after the button is released.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its Single-Photon Emission Tomography (SPECT) systems and SPECT scanning systems on June 17, 2019. This action was taken under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall stemmed from a critical issue identified in the manual controller of the BrightView series cameras. This defect causes the systems to exhibit spontaneous, uninstructed movement or continued movement after the control button has been released, potentially affecting patient safety. The affected products encompass specific models and batches, which were registered under CFDA (Imported) Nos. 2014 No. 3331168 and 2011 No. 3333467 (Revised). Philips is taking this necessary step to address the identified product malfunction and ensure the safety and reliability of its medical devices. Detailed information regarding the scope of the recall, including specific product models, specifications, and batch numbers, is available in the accompanying "Medical Device Recall Event Report Form" accessible through the NMPA website.

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/