Tag: class 1 recall

All

SunMed Holdings Removes Adult Manual Resuscitator Devices

The Class I recall involves devices with incorrectly assembled B/V filters.

All

Certain Draeger Medical Ventilators Get Class I Recall

Certain Draeger ventilators reportedly stopped ventilation because of a depleted battery, even after being re-connected to AC power.

All

Reworked Philips Ventilators Get Class I Recall for Potential Foam Debris Issues

Philips Respironics recalled certain reworked ventilators for issues related to foam adhesion failure and foam debris.

All

SunMed Holdings Removes Adult Manual Resuscitator Devices

The Class I recall involves devices with incorrectly assembled B/V filters.

LivaNova Recalls Circulatory Support System for Software Malfunction Risk

Oct 7, 2022

LivaNova is recalling the LifeSPARC Controller, part of the LifeSPARC circulatory support system, due to a software malfunction.

FDA Hands Philips its 5th Class I Recall of the Year for Faulty Ventilators

Sep 28, 2022

Philips’ recent recall regarding certain BiPAP machines has been classified as a Class I recall, according to the U.S. FDA.

Medtronic Recalls Endotracheal Tubes for Risk of Airway Obstruction

Sep 23, 2022

Medtronic is recalling certain endotracheal tubes after receiving customer complaints about obstruction of the tubes while used on patients.

Malfunctioning Integra Intracranial Monitor Was Used on Patient Who Died: FDA

Sep 6, 2022

The U.S. FDA has identified one patient death that was tied to the use of Integra LifeSciences CereLink ICP monitors.

Getinge’s Recall of 11,000 Ventilators Labeled Class I Event by FDA

Aug 29, 2022

Getinge is recalling several different types of ventilators in its device portfolio that are being labeled as a Class I event by the FDA.

Medtronic Recalls Ventricular Assist Device Batteries

Aug 26, 2022

Medtronic is recalling HeartWare Ventricular Assist Device System batteries due to their ability to experience electrical faults that cause them to unexpectedly fail.

All

Medtronic Recalls Defibrillator Devices for Short Circuit Alert Risks

Medtronic is recalling Cobalt/Crome implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.