# China NMPA Product Recall - Electrocardiograph (ECG-2360)

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-optoelectronic-medical-electronic-instruments-co-ltd/e59b912a-07ac-4d4d-8fce-a59d9be1f762
Source feed: China

> China NMPA product recall for Electrocardiograph (ECG-2360) by Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. published May 31, 2021. Recall level: Level 3 Recall. Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. initiated a voluntary Level III rec

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. is voluntarily recalling electrocardiographs (ECG machines).
- Company Name: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd.
- Publication Date: 2021-05-31
- Product Name: Electrocardiograph (ECG-2360)
- Recall Level: Level 3 Recall
- Recall Reason: The software release version number of the ECG-2360 electrocardiograph on the market is 02, which is inconsistent with the software release version 01 at the time of product registration (there are no differences in product functions or performance between the two software versions, only an error in version marking).
- Discovering Company: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd.
- Manufacturing Company: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd.
- Summary: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. initiated a voluntary Level III recall of its Electrocardiographs (ECG machines) and ECG meters, specifically model ECG-2360. This action, publicly announced by China's National Medical Products Administration (NMPA) on May 31, 2021, addresses a discrepancy found in the product's software. The primary issue identified was that the software release version number (02) on marketed units was inconsistent with the version (01) submitted during the initial product registration process. The company clarified that this was purely a version marking error, asserting that there are no actual differences in product function or performance between the two software iterations. Operating under the regulatory framework of the NMPA, the company is taking proactive steps to ensure compliance with its registered product information. This voluntary recall demonstrates the manufacturer's commitment to maintaining product consistency and regulatory adherence, even for issues that do not directly impact device safety or clinical efficacy. Further details on specific affected batches, models, and specifications are contained within the "Medical Device Recall Event Report Form" provided by the NMPA.

Company: https://www.globalkeysolutions.net/companies/shanghai-optoelectronic-medical-electronic-instruments-co-ltd/0ee5a2e4-da50-48dc-874b-88344523fa76