FDA Issues Warning Letter to Zoll Medical Over Quality System Violations
The agency cites failures in corrective actions, design validation, and reporting for ventilators, defibrillators, and sensors.
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Search Results for: philips recall
FDA Issues Alert for Aligned Medical Solutions Angiographic Syringe Kits
The recall involves convenience kits containing syringes that may disconnect during use, posing risks of blood loss and air embolism.
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Philips Issues Correction for Trilogy Evo Ventilators Following FDA Class I Recall
The Food and Drug Administration identifies the software update and nebulizer restrictions as the most serious type of recall.
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FDA Clears New Device for Transseptal Heart Access
The system is designed to improve workflow efficiency and safety during minimally invasive left-heart procedures.
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The Factors Behind OEM vs Aftermarket Parts Decisions
For HTM teams, parts sourcing decisions depend on far more than price or availability.
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