Recall Z-1813-2024 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Philips Respironics, Inc.
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H
| Date | May 24, 2024 (initiated Mar 26, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | The firm notified customers via mailed URGENT Medical Device Recall notice on March 26, 2024. The notice described the product, problem and actions to be taken. The firm reminded customers to refer to the user manual and to perform a clinical assessment prior to placing a patient on the ventilator to ensure that: 1. The device is appropriately set for patient requirements. 2. Alternate ventilation equipment is available. 3. Alternative monitoring (such as alarming Pulse Oximeter or Respiratory) is used where appropriate. Depending on the level of ventilatory support required, customers were |
| Quantity | 6 US, 60,417 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.