# China NMPA Product Recall - ECG Management System

Source: https://www.keypedia.com/records/china_product_recall/philips-medical-systems/06646aee-9146-49f8-8b4b-61be8f488190
Source feed: China

> China NMPA product recall for ECG Management System by Philips Medical Systems published September 23, 2014. Recall level: . The National Medical Products Administration (NMPA) issued a public notice on September 23, 2014, co

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems, Inc. of the United States, is recalling its ECG management system.
- Company Name: Philips Medical Systems
- Publication Date: 2014-09-23
- Product Name: ECG Management System
- Recall Reason: If multiple Quinton Stress ECG records are processed simultaneously during IECG input, a patient's XML patient ID may be incorrectly linked to another patient's report in the processing sequence. The Stress ECG record can be recovered using the XML file information. The recovered record will contain two different patient identifiers, which is dangerous. This problem does not occur if the Stress ECG record is output to the IECG system after each stress test is completed, because the IECG system does not process multiple records simultaneously. (Internal Document No.: FCO 86000214)
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: The National Medical Products Administration (NMPA) issued a public notice on September 23, 2014, concerning a voluntary recall initiated by Philips Medical Systems for its ECG Management System (Model 860426, Registration Certificate No.: CFDA (Imported) No. 20132700072). Philips (China) Investment Co., Ltd. formally reported this recall on September 17, 2014, referencing an internal report dated August 14, 2014. The core issue stemmed from a critical malfunction: when multiple Quinton Stress ECG records were processed concurrently using software option C61, a patient's XML identifier could be erroneously linked to another patient's report within the processing sequence. This defect could result in a single recovered record containing two distinct patient identifiers, posing a serious threat to patient data accuracy and safety. The problem was confirmed not to occur if Stress ECG records were output individually after each test. Philips stated that the specific affected product batches were not sold or imported into the Chinese market. As a regulatory action, the NMPA instructed all provincial food and drug administration departments to oversee and manage such products, irrespective of their local distribution status, underscoring the broad reach of regulatory vigilance in ensuring medical device safety and data integrity.

Company: https://www.keypedia.com/companies/philips-medical-systems/91e33b43-88a2-4a53-9bcd-1d32f1abde47