Tag: class 1 recall

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Zyno Medical Recalls Infusion Pumps Over Software Issue

Certain Z-800 series infusion pumps may malfunction due to unverified software, prompting a Class I recall by the FDA.

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Johnson & Johnson Megadyne Electrodes Nab Class 1 Recall

The FDA has labeled the recall of two types of Megadyne electrodes manufactured by Johnson & Johnson’s Ethicon as a class I, the most serious.

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GE HealthCare Recalls Nuclear Medicine Systems

GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two of its mechanisms.

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Zyno Medical Recalls Infusion Pumps Over Software Issue

Certain Z-800 series infusion pumps may malfunction due to unverified software, prompting a Class I recall by the FDA.

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.

Medtronic Recalls Defibrillator Devices for Short Circuit Alert Risks

Aug 22, 2022

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

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Getinge Recalls Anesthesia Systems for Broken Suction System Power Switches

Getinge is recalling the Flow-c and Flow-e anesthesia systems after reports of cracked or broken on/off switches on the system’s suction unit.