FDA: Reworked Philips Trilogy Ventilators Have Additional Safety Issues
The FDA reports that Philips Trilogy ventilators reworked as a part of the June 2021 recall have two new potential issues that may affect performance and safety.
Category: Recalls & Advisories
Recalls & Advisories
Latest
Recalls & Advisories
Latest
GE Healthcare Recalls Carescape R860 Ventilator Batteries
GE Healthcare is recalling Carescape R860 ventilator backup batteries, including replacement backup batteries, because the batteries may run out before they are expected to do so, according to an FDA advisory.
Recalls & Advisories
Latest
Class I Recall for Hillrom Volara System
Baxter International Inc has issued an Urgent Medical Device Correction for the Hillrom Volara System (home care) over a possible risk of oxygen desaturation or barotrauma.
Syringes of Symjepi Epinephrine Recalled
Adamis Pharma issued a recall of certain lots of Symjepi (epinephrine) Injection prefilled single-dose syringes due to the potential clogging of the needle preventing the dispensing of epinephrine, according to an FDA alert.
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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.
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FDA Orders Philips Respironics to Notify Patients of Recall for Ventilators, CPAP Devices
The FDA ordered Philips to notify patients and DMEs of the company’s June 14, 2021 recall of certain ventilators, CPAP, and BiPAP machines.
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Class I Recall for E25Bio Tests for COVID-19
E25Bio is recalling its COVID-19 Direct Antigen Response Tests (DART) for several reasons, particularly that these tests were marketed and distributed to U.S. customers without authorization, clearance, or approval from the FDA.
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Class I Recall for Base10 Genetics RNAstill
Base10 Genetics is recalling the RNAstill MTM specimen collection kits because they were distributed without proper premarket clearance from the FDA.
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Class I bellavista Ventilator Recall
According to an FDA alert, Vyaire Medical is recalling the bellavista 1000 and 1000e Series Ventilators after reports of ventilators failing to ventilate and generating a technical failure alarm, with specific software versions and configure combinations.
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Vyaire Medical Issues bellavista Ventilator Voluntary Correction
Vyaire Medical and imtmedical ag have initiated a voluntary field correction for certain bellavista ventilators due to risk the ventilators can cease ventilation and generate a technical failure alarm 305.
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FDA Warns Consumers Not to Use E25Bio COVID-19 Tests
The US FDA is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test (DART), according to an agency alert.
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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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FDA Signals Blood Collection Equipment Shortage
The US FDA updated the medical device shortage list to include all blood specimen collection tubes to the testing supplies and equipment – specimen collection category.
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FDA: Stop Using LuSys Laboratories COVID-19 Tests
The FDA has warned consumers to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test.
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