Philips Respironics V60 Ventilator Recall for Navigation Ring Issues
Respironics is recalling 3,752 V60 Ventilators worldwide due to potential navigation ring malfunctions that may cause erratic parameter changes or inoperability.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a life-support device (ventilator) where erratic parameter changes or inoperability pose a risk of harm, even though specific injuries are not reported in the source text.
Plain-English summary
Respironics California, LLC is recalling 3,752 Philips Respironics V60 Ventilators (Part Number 1076709) due to potential issues with the navigation ring interface. The recall covers units distributed worldwide, including the United States, Guam, Puerto Rico, and numerous international markets.
The identified issues include the navigation ring becoming inoperative or operating intermittently. Additionally, the navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments. These malfunctions could affect the device's ability to maintain intended settings.
Healthcare facilities and users should check their V60 Ventilator serial numbers against the list provided in the official recall notice. If a unit is affected, users should contact Respironics for instructions on corrective actions. The recall is classified as FDA Class II.
The recalled product
- Product
- Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
- Manufacturer
- Respironics California, LLC
- Category
- Medical Device — Ventilator
- Affected units
- 3,752
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model: V60 Part Number: 1076709 V60 Ventilator
- JAPAN OPT: CFLEX
- AVAPS
Distribution
Part of a larger recall action
This product is one of 16 recalled by Respironics California, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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