# China NMPA Product Recall - Injection pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenzhen-pacom-medical-instruments-co-ltd/e4825af9-4ae2-448a-b3a0-2499468b4b21/
Source feed: China

> China NMPA product recall for Injection pump by Shenzhen Pacom Medical Instruments Co., Ltd. published September 16, 2019. Recall level: Level 3 Recall. Shenzhen Haoke Medical Instrument Co., Ltd. initiated a voluntary Level III recall of its HK-400 inj

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenzhen Haoke Medical Instruments Co., Ltd. is voluntarily recalling its infusion pumps.
- Company Name: Shenzhen Pacom Medical Instruments Co., Ltd.
- Publication Date: 2019-09-16
- Product Name: Injection pump
- Recall Level: Level 3 Recall
- Recall Reason: The software version of this batch of machines was incorrectly burned, and pressing the alarm clear button will clear some alarms, which does not meet the product technical requirements.
- Discovering Company: Shenzhen Haoke Medical Instruments Co., Ltd.
- Manufacturing Company: Shenzhen Pacom Medical Instruments Co., Ltd.
- Summary: Shenzhen Haoke Medical Instrument Co., Ltd. initiated a voluntary Level III recall of its HK-400 injection pumps, specifically batch number 201901006. This action, reported to the National Medical Products Administration (NMPA) on September 6, 2019, and publicly announced on September 16, 2019, addresses a critical software issue. The recall stems from a software version burning error that causes the alarm deactivation button to clear certain alarms, violating the product's technical requirements. A total of 20 units were affected, with 9 units sold in China. The company confirmed that, as of the report date, no adverse event reports related to this software defect had been received. Shenzhen Haoke will take two primary corrective actions: notifying all affected customers through formal letters to inform them about the issue and the recall process, and directly contacting these customers to schedule and perform a software upgrade on the affected injection pumps to rectify the error. This recall underscores the importance of adhering to regulatory standards for medical devices registered under certificate number 粤械注准20172541482.

Company: https://www.globalkeysolutions.net/companies/shenzhen-pacom-medical-instruments-co-ltd/943c7544-461c-42a4-9b08-814d5b6929e8/