Baxter Issues Device Correction for Life2000 Ventilator
Patient oxygen desaturation events can occur when the Life2000 ventilation system is connected with a third-party oxygen concentrator, the FDA says.
Tag: product recall
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Philips Provides Update on Medical Device Reports Linked to Recall
Philips Respironics: Submission of a medical device report itself is not evidence that the device caused or contributed to the adverse outcome or event.
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Class I Recall Issued for Philips V60 and V60 Plus Ventilators
Philips Respironics is recalling certain V60 and V60 Plus ventilators due to an expired adhesive in what the FDA has labeled a Class I recall.
FDA Cautions Against Using Empowered Diagnostics COVID-19 Tests
The US FDA is warning people to stop using two Empowered Diagnostics COVID-19 tests because they are mislabeled as authorized by the FDA.
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FDA Update on Trilogy Evo Recall
The FDA says an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain ventilators.
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Puritan Bennett 980 Ventilator Recall
Covidien, LP (part of Medtronic) is recalling its Puritan Bennett 980 Series Ventilator due to a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop working as intended, according to an FDA alert.
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SoClean Sues Philips Over ‘False And Misleading Statements’ Regarding CPAP Product Recall
SoClean Inc has filed a federal lawsuit in the United States District Court for the District of Massachusetts against Philips, for statements made about Philips’ CPAP and bilevel recall.
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Philips Statement on V60/V60 Plus Ventilator Recall
Philips Healthcare provided a statement in response to RT’s recent article, “Philips V60, V60 Plus HFO-equipped Ventilators Recalled Over Risk of Reduced Oxygen.”
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Philips V60, V60 Plus HFO-equipped Ventilators Recalled Over Risk of Reduced Oxygen
According to an FDA alert, Philips Respironics is recalling the V60 and V60 Plus ventilators that provide High Flow Therapy (Software Version 3.00 and Software Version 3.10) due to the risk to the patients who rely on the ventilator to provide high flow oxygen therapy if the system pressure reaches the default maximum limit.
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FAQs on the Philips CPAP, BiPAP, and Ventilator Recall
The FDA has provided answers to frequently asked questions related to the Philips CPAP, BiPAP, and ventilator recall.
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FDA: Philips Recall Is ‘Most Serious Type of Recall’
The FDA says the Philips CPAP, BiPAP, and ventilator recall is a Class I recall, the most serious type of recall, which can cause death or injury.
Read MoreFDA: Pfizer Expands Recall of Smoking Cessation Drug Chantix
Pfizer has expanded its voluntary recall of smoking cessation drug Chantix, according to an update posted on the US Food and Drug Administration (FDA) website.
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Are CPAP Filters a Viable Interim Solution for the Philips Recall?
As patients await repaired or replaced CPAP devices, many turn to in-line filters that are readily available over the internet.
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Medtronic Recalls Thoracic Stent Graft Systems
Medtronic has issued a voluntarily global recall of unused Medtronic Valiant Navion thoracic stent graft systems and informed physicians to immediately cease use of the device until further notice.
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Class I Recall for Teleflex Comfort Flo Humidification Systems
According to the FDA, there is a risk for water to flood the column and enter the circuit in the system, then enter the nose and lungs of the patient.
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