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

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthineers-co-ltd/6b478498-3f22-46ce-8e3e-d6a55ac3eafc/
Source feed: China

> China NMPA product recall for Single-photon emission and X-ray computed tomography (SPECT) system; Single-photon emission and X-ray computed tomography (SPECT) system by Siemens Healthineers Co., Ltd. published August 28, 2020. Recall level: Level 2 Recall. On August 28, 2020, Siemens Healthineers initiated a voluntary Class II recall for specific Single-P

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthineers is voluntarily recalling its Single Photon Emission Tomography (SPA) systems.
- Company Name: Siemens Healthineers Co., Ltd.
- Publication Date: 2020-08-28
- Product Name: Single-photon emission and X-ray computed tomography (SPECT) system; Single-photon emission and X-ray computed tomography (SPECT) system
- Recall Level: Level 2 Recall
- Recall Reason: In rare cases, Symbia T system detectors that have been in use for more than 10 years may experience slow movement, posing a certain degree of application problem.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthineers Co., Ltd.
- Summary: On August 28, 2020, Siemens Healthineers initiated a voluntary Class II recall for specific Single-Photon Emission Tomography (SPEE) systems, including certain Symbia T models. This action was communicated through the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The basis for the recall was the discovery that a small number of Symbia T system detectors, particularly those in use for over a decade, might exhibit slow movement under very specific operational conditions. This potential malfunction could lead to application problems during clinical use. Siemens Healthineers confirmed that no patient injuries resulting from this issue have been reported. As a proactive measure to address this, Siemens Healthineers will conduct preventive maintenance on all identified affected equipment. Detailed information concerning the affected models, specifications, and batches is provided in the "Medical Device Recall Event Report Form," underscoring the company's commitment to regulatory compliance and patient safety.

Company: https://www.globalkeysolutions.net/companies/siemens-healthineers-co-ltd/92a17b04-898c-4eba-81aa-91900b470181/