BiPAP V30 Auto Ventilator, Part Number 1111178
Reported: May 29, 2024 Initiated: March 26, 2024 #Z-1812-2024
Product Description
BiPAP V30 Auto Ventilator, Part Number 1111178
Reason for Recall
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Details
- Recalling Firm
- Philips Respironics, Inc.
- Units Affected
- 5,958 US; None OUS
- Distribution
- Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.
- Location
- Murrysville, PA
Frequently Asked Questions
What product was recalled? ▼
BiPAP V30 Auto Ventilator, Part Number 1111178. Recalled by Philips Respironics, Inc.. Units affected: 5,958 US; None OUS.
Why was this product recalled? ▼
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2024. Severity: Critical. Recall number: Z-1812-2024.
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