# China NMPA Product Recall - Respironics V60 Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/respironics-california-inc/bb1ecce3-f9c8-48b4-bf97-a837748af4c5/
Source feed: China

> China NMPA product recall for Respironics V60 Ventilator by Respironics California, Inc. published July 30, 2013. Recall level: . The National Medical Products Administration (NMPA) announced a recall by Respironics California, In

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Respironics California, Inc. is recalling its ventilators.
- Company Name: Respironics California, Inc.
- Publication Date: 2013-07-30
- Product Name: Respironics V60 Ventilator
- Recall Reason: Routine product monitoring revealed an issue with the PIC software of the power management board component of the V60 ventilator. In rare cases, components on the power management board component malfunction, subsequently resulting in: 1) a short circuit to ground on the Vmain of the power management board component; 2) ventilator shutdown; and 3) the software repeatedly looping through its partial initialization procedure and power-on self-test (POST), indicating that alarms indicating ventilator cessation may not be triggered.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Respironics California, Inc.
- Summary: The National Medical Products Administration (NMPA) announced a recall by Respironics California, Inc. for its V60 ventilators, reported on July 30, 2013. The recall, managed in China by Philips (China) Investment Co., Ltd., addresses a critical malfunction in the power management board. Routine product monitoring identified an issue with the power management board's PIC software. This defect can, in rare cases, lead to a short circuit, causing the ventilator to shut down. A significant concern is that this malfunction may also prevent the alarm for cessation of respiratory therapy from triggering, posing a serious patient safety risk. The recall affects V60 ventilators and accessory power management boards shipped globally before April 1, 2013, encompassing 16,804 units. Under the NMPA's regulatory guidance, Respironics California, Inc. is implementing two corrective actions. These include upgrading the PIC software for the power management board assembly in all affected V60 ventilators and replacing any unused power management boards shipped before the specified date. These actions are mandated to resolve the identified safety issues and restore product reliability.

Company: https://www.globalkeysolutions.net/companies/respironics-california-inc/74e0ff42-7ab6-4eae-b35d-81406bd7e09a/