FDA Proposes Order Forcing Philips to Repair, Replace or Refund All Recalled Ventilators
The FDA is proposing an order be issued that would require Philips Respironics to address recalled devices, including millions of ventilators.
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Medtronic HVAD System May Have Potential Pump Malfunction
The Medtronic Heartware Ventricular Assist Device (HVAD) System may have a welding defect in the internal pump causing a malfunction.
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Medtronic’s Covidien Gets Class I Recall for Puritan Bennett 980 Ventilators
Covidien, LP is recalling its Puritan Bennett 980 Series Ventilator due to a capacitor manufacturing assembly error.
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Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk
Medtronic is recalling its Harmony Delivery Catheter due to a risk where the bond holding the capsule at the end of the catheter may break.
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Philips Investigates Reports of One Death, Four Injuries Potentially Tied to Ventilator Recall
Earlier this week, the U.S. FDA revealed that the Philips’ Respironics V60 ventilator received a Class 1 recall due to an electrical circuit fault that can use the device to malfunction. Now, Philips is investigating one patient death and four reports of patient harm possibly related to the recall.
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