Hong Kong Issues Warnings for Pacing Leads, Stents, Ventilators

Hong Kong’s Department of Heath issued safety warnings for Boston Scientific Ingevity MRI endocardial pacing leads and Percuflex Urinary Diversion stents, Draeger Medical GmbH Oxylog 3000 and Oxylog 3000plus ventilators, and Brainlab radiation treatment software — all of which may have manufacturing or production defects.

Boston Scientific is implementing a voluntary field safety corrective action for 15 of the pacing leads and recalling lots of Percuflex Urinary Diversion Stent Kits in Japan, because the wrong size connectors were included with the stents.

Draeger Medical GmbH issued a medical device safety alert concerning its Oxylog 3000 and Oxylog 3000plus ventilators, due to a manufacturing defect. Brainlab issued a medical device safety alert concerning its iPlan RT, iPlan RT Dose (all versions) and BrainSCAN (discontinued) radiation treatment software when using the pencil beam algorithm for dose calculation of small MLC-shaped fields.