# China NMPA Product Recall - Operating table system

Source: https://www.globalkeysolutions.net/records/china_product_recall/maquet-gmbh/7b3b29c3-9f94-49fe-950c-4c89f75c3cbf/
Source feed: China

> China NMPA product recall for Operating table system by MAQUET GmbH published December 07, 2016. Recall level: Level III. Maikewei (Shanghai) Medical Equipment Co., Ltd., the Chinese responsible unit for MAQUET GmbH, initi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maikewei (Shanghai) Medical Equipment Co., Ltd. voluntarily recalls operating table systems
- Company Name: MAQUET GmbH
- Publication Date: 2016-12-07
- Product Name: Operating table system
- Recall Level: Level III
- Recall Reason: The manufacturer received a complaint during post-market product monitoring regarding damage to the engagement surface of the accessory adapter caused by the use of the headframe. Testing confirmed that the materials used to manufacture the accessory adapter failed to meet Maquet's specifications. The stiffness and flexibility of the materials used were lower than the design specifications. Further investigation confirmed that the accessory adapter could withstand 11 kg at 300 mm, but did not meet the design strength requirements.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: MAQUET GmbH
- Summary: Maikewei (Shanghai) Medical Equipment Co., Ltd., the Chinese responsible unit for MAQUET GmbH, initiated a voluntary Level III recall of its Operating Table System's accessory adapters. The recall, reported on August 12, 2016, and published by the National Medical Products Administration (NMPA) on December 7, 2016, stemmed from a post-market complaint regarding material failure. Investigations confirmed that the materials used in accessory adapters (model 1180.10A0, part 600525A0), manufactured since 2002, did not meet Maquet's internal specifications for stiffness, flexibility, and overall design strength, potentially affecting patient safety. Although no personal injuries were reported, the company acted preventatively to enhance medical device safety. The NMPA-indexed recall (JGXX-2016-10411) affects three units imported into China. Required actions include issuing a "User Safety Notice" to customers, instructing them to cease using the faulty adapters, and providing free replacements for all affected accessory adapters globally.

Company: https://www.globalkeysolutions.net/companies/maquet-gmbh/1bba0ce2-8792-4b7e-9693-be580a1d5eff/