BiPAP A30 Ventilators Recalled for Improper Respiratory Failure Indication
Philips Respironics recalls BiPAP A30 and BiPAP Hybrid A30 ventilators due to labeling deficiency. The devices do not indicate for use in patients with respiratory failure.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification indicates the device could cause serious injury or death. The recall addresses a labeling deficiency regarding indications for use in respiratory failure patients. No reported illnesses or injuries are mentioned in the source material.
Plain-English summary
Philips Respironics, Inc. is recalling BiPAP A30 Ventilators and BiPAP Hybrid A30 Ventilators. These noninvasive ventilation devices are intended for use in adult and pediatric patients weighing more than 10 kg. The devices have been distributed worldwide.
The FDA has classified this recall as Class I due to an indication labeling deficiency. The devices do not indicate for use in patients with respiratory failure. This missing indication creates a risk that the devices could be used in a patient population for which they were not designed or evaluated.
Patients and healthcare providers should review the product labeling to confirm proper indications for use. Those with questions or concerns regarding the BiPAP A30 or BiPAP Hybrid A30 should contact Philips Respironics, Inc. for guidance on appropriate device use and any necessary corrective actions.
The recalled product
- Product
- BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- mis-labeling
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 (20)
- BiPAP A30 Part No. 1111143
- 1111144
- CN1111143
- 1111145
- 1111147
- 1111149
- 1111148
- 1111150
- 1116155
- BR1111143
- 1111144M
- 1111144L
- 1111144V
- R1076491
- 1111154
- R1111143
- 1101109
- 1109594
- 1076540
- 1076581
Distribution
Distributed nationwide across the United States.
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