# China NMPA Product Recall - Electrophysiological navigation system (trade name: CARTO 3)

Source: https://www.globalkeysolutions.net/records/china_product_recall/biosense-webster-inc/1c5bf411-940d-46d1-af01-31bb93e8c7f6/
Source feed: China

> China NMPA product recall for Electrophysiological navigation system (trade name: CARTO 3) by Biosense Webster Inc. published December 07, 2016. Recall level: Level II. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., under the oversight of the National Medical 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls electrophysiological navigation systems.
- Company Name: Biosense Webster Inc.
- Publication Date: 2016-12-07
- Product Name: Electrophysiological navigation system (trade name: CARTO 3)
- Recall Level: Level II
- Recall Reason: Biosense Webster discovered that clinical specialists were transferring CARTO3 systems between hospitals for surgical use without having the device reinstalled by technical service personnel as required by the Instructions for Use (IFU). CARTO3 IFUs stipulate that if the system is transferred, it must be tested before the next use to ensure that environmental changes will not adversely affect system operation. The system can only be used clinically after full testing and approval by Biosense Webster technical service personnel. Currently, no adverse events have been reported due to unauthorized movement of the CARTO3 system; however, failure to fully test and approve the system after transfer may affect machine performance. This could cause customer inconvenience, surgical delays due to functional malfunctions (such as inaccurate magnetic positioning), and in extreme cases, serious damage.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Biosense Webster Inc.
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., under the oversight of the National Medical Products Administration (NMPA), initiated a voluntary Class II recall for its Electrophysiological Navigation System, known as CARTO 3. This action was officially published by the NMPA on December 7, 2016, following the company's internal report dated September 8, 2016. The recall encompassed 54 units of the CARTO 3 system in China. The primary concern arose from the improper transfer of these systems between hospitals by clinical specialists. Crucially, required retesting by Biosense Webster technical service personnel, as stipulated in the product's Instructions for Use, was not performed before subsequent clinical applications. This non-compliance posed a risk of system operational problems, including inaccurate magnetic positioning and potential surgical delays, with a hypothetical risk of serious malfunction. No adverse events had been reported directly linked to this issue at the time of the recall. Johnson & Johnson implemented corrective measures by notifying all affected customers and deploying technical service personnel to conduct comprehensive retesting on every affected machine, ensuring correct system functionality and obtaining relevant technical service reports.

Company: https://www.globalkeysolutions.net/companies/biosense-webster-inc/1e41796e-2ddf-4c5f-ba8b-efc71a994f80/