Class I Ventilator Recalls Announced by Philips, Baxter, and Zoll Medical

The FDA has issued Class I recall notices, its most severe level, for ventilators produced by Philips, Baxter, and Zoll Medical due to various issues.

Philips Respironics: Several models of Philips Respironics’ BiPAP machines, designed for home use by people with obstructive sleep apnea, are being recalled. Problems with these devices have led to interruptions in therapy, potentially causing hypoventilation, hypoxemia, and respiratory failure. The FDA has received reports of 952 injuries and 65 deaths related to these devices among tens of thousands distributed. 

The affected models—BiPAP V30, A30, and A40—do not need to be returned but require updated instructions. A critical failure involves the “Ventilator Inoperative” alarm, which may cause the machine to reboot intermittently for five to ten seconds, restarting with either patient settings or factory defaults. If the device reboots three times within 24 hours, it might enter an inoperative state. Philips alerted users in late March, advising patients to switch to an alternate device if problems occur and ensure correct settings. An optional hard reboot can temporarily restore function.

Philips’ OLA+ Ventilator (OmniLab Advanced+), used in hospitals and sleep labs, is also under recall due to similar alarm failures. These issues have resulted in 15 injuries and one death. Philips plans to issue a software patch for the approximately 10,000 distributed OLA+ machines.

Baxter Healthcare: Baxter has notified healthcare providers about a potential issue with the battery charger dongles for its Life2000 ventilator, affecting about 2,500 units nationwide. The problem can cause the system to fail to charge or charge intermittently. Baxter recommends inspecting the battery chargers for damage and replacing them if necessary. Patients can continue to use the system once it is confirmed that there is no issue with the battery charging. 

Zoll Medical: Zoll Medical is updating the instruction manuals for its 731 series of ventilators, including the AEV, EMV+, and Eagle II models. These portable machines are used in hospitals and patient transport. The previous lack of detailed instructions could lead to users placing the devices too close to the MRI machine, potentially triggering alarms or causing malfunctions. The FDA has reported no injuries or deaths associated with this issue.

The FDA has elevated the recalls for ventilators from Philips, Baxter, and Zoll Medical to Class I due to significant risks associated with their use. Philips’ recalls involve both home-use BiPAP machines and hospital-use OLA+ Ventilators due to alarm failures causing interruptions in therapy and potential respiratory issues. Baxter’s recall addresses battery charging issues with the Life2000 ventilator, while Zoll Medical’s recall involves updating manuals to prevent malfunctions near MRI machines. These actions aim to mitigate risks and ensure patient safety.