# China NMPA Product Recall - Respironics V60 Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/respironics-california-inc/87cb3a74-9db8-47af-a76b-45b9847db6b6/
Source feed: China

> China NMPA product recall for Respironics V60 Ventilator by Respironics California, Inc. published October 15, 2012. Recall level: Level 1 Recall. Respironics California, Inc. initiated a Class I recall for specific batches of its Respironics V60 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Respironics California, Inc. is recalling its Respironics V60 Ventilator ventilator.
- Company Name: Respironics California, Inc.
- Publication Date: 2012-10-15
- Product Name: Respironics V60 Ventilator
- Recall Level: Level 1 Recall
- Recall Reason: Some turbine motors used in the V60 do not meet design requirements (the fan blades are not correctly installed on the shaft), which may cause the turbine to malfunction, resulting in the V60 ventilator losing its ventilation function.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Respironics California, Inc.
- Summary: Respironics California, Inc. initiated a Class I recall for specific batches of its Respironics V60 Ventilator ventilators due to a critical manufacturing defect. The recall, publicly announced by the National Medical Products Administration (NMPA) on October 15, 2012, stems from an internal report forwarded by Philips (China) Investment Co., Ltd. The primary issue identified was that some turbine motors within the V60 ventilators did not meet design specifications, with fan blades incorrectly mounted on their shafts. This flaw could lead to turbine malfunction, potentially causing the ventilator to lose its essential ventilation function, although the device is designed to issue audible and visual alarms in such an event. No injuries related to the defect were reported, despite two malfunction incidents. Under the NMPA's regulatory oversight, Respironics California, Inc. committed to replacing all affected turbine motors. The recall process was scheduled for completion by March 14, 2013, executed in collaboration with Philips' distributors, with regional food and drug administrations tasked with enhanced product supervision. The recall highlights the importance of manufacturing quality in life-sustaining medical devices.

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