# 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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/91dba66e-d13c-4d4a-83ed-cf4400720019/
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; Forte gamma camera system; Single-photon emission and X-ray computed tomography (SPECT) imaging system by Philips (China) Investment Co., Ltd. published January 28, 2021. Recall level: Level 2. Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall for several models of its

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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; single-photon emission computed tomography (SPECT) systems; Forte gamma camera systems; and single-photon emission and X-ray computed tomography (SPECT) systems.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2021-01-28
- Product Name: 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
- Recall Level: Level 2
- Recall Reason: Because when using the JETStream WorkSpace thyroid analysis application to calculate thyroid uptake values, in some cases, the calculated thyroid uptake value may be lower than the actual uptake value when the transfer coefficient (TCO) parameter is used.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: 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.

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