FDAnews Device Daily Bulletin

UK Recalls Infant Ventilators and Tests, Orthopedic Surgical Tools

Dec. 16, 2016

The UK’s Medicines and Healthcare products Regulatory Agency released urgent recall notices for a range of medical devices, including Smith & Nephew’s Reflection dead blow mallet, Roche’s neonatal cobas test, Acutronic’s neonatal ventilator and Zimmer Biomet’s bone cement.

Hirzel, Switzerland-based Acutronic issued an urgent field safety notice for its fabian neonatal ventilators that could stop working.

The recall affects the fabian high frequency oscillation (HFO) and oxygen therapy device for neonatal and pediatric patients and its fabian Therapy evolution devices used in NICU units. — Jeff Kinney

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