# China NMPA Product Recall - Refractometer, RMK-150

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-xiongbo-precision-instruments-co-ltd/8e2c1a2d-d523-44d9-8419-2a5154db47b6/
Source feed: China

> China NMPA product recall for Refractometer, RMK-150 by Shanghai Xiongbo Precision Instruments Co., Ltd. published August 08, 2017. Recall level: Level 3. Shanghai Xiongbo Precision Instruments Co., Ltd. initiated a Class III voluntary recall of its Optom

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Xiongbo Precision Instruments Co., Ltd. voluntarily recalls optometry equipment.
- Company Name: Shanghai Xiongbo Precision Instruments Co., Ltd.
- Publication Date: 2017-08-08
- Product Name: Refractometer, RMK-150
- Recall Level: Level 3
- Recall Reason: The instruction manual does not include the fuse model and rating.
- Discovering Company: Shanghai Xiongbo Precision Instruments Co., Ltd.
- Manufacturing Company: Shanghai Xiongbo Precision Instruments Co., Ltd.
- Summary: Shanghai Xiongbo Precision Instruments Co., Ltd. initiated a Class III voluntary recall of its Optometristors (models RMK-150 and RJK-150) on August 8, 2017, under the oversight of the National Medical Products Administration (NMPA). The core issue identified was a critical omission in the product instruction manuals, which failed to specify the model and rated value of the fuse. This deficiency in the user documentation affects safety information for a device designed to measure human eye refractive power. As a required action under the NMPA's regulatory framework, the company is recalling all instruction manuals for the affected batch of RJK-150 optometrists to rectify the missing fuse details. This measure ensures users receive complete and accurate operational and safety documentation. The recall involved 307 units of Optometrist PMK-150 sold in China, reflecting the company's commitment to compliance and product safety through transparent reporting and corrective actions.

Company: https://www.globalkeysolutions.net/companies/shanghai-xiongbo-precision-instruments-co-ltd/55bbdccc-5511-49c5-8bff-60fbc590727f/
