규제 업데이트

Stryker reports a labeling error in one lot of T2 Alpha IMN advanced locking screws, which contain 75 mm screws instead of the specified 57.5 mm.

Air bubbles in the monoblock oil of Philips Unity and BV Pulsera C‑arm units can cause flashovers, preventing X‑ray generation during early use after long storage.

MHRA published a series of Field Safety Notices covering devices such as Acu‑Loc 2, bedside monitors, orthopaedic cements and a peripheral artery stent‑graft between 31 Aug and 4 Sep 2026.

Health Canada warns that certain printer and modem access port connectors on Stryker LifePak R35 monitor‑defibrillators may not be fully seated during production.

Stryker discovered that some LifePak R-35 units may have printer and modem access port connectors not fully seated, potentially appearing flush or recessed.

Boston Scientific is recalling Imager II Angiographic Catheters after discovering reduced stabilizing agents in the tip, which may increase risk of tip degradation and detachment.

Boston Scientific is recalling Imager II catheters due to reduced stabilizing agents in the tip, which may increase risk of tip degradation and detachment.

Gore discovered some VIABAHN® devices were processed on equipment outside validated range, risking incorrect distal tip bonding.

The UK Medicines and Healthcare products Regulatory Agency listed several field safety notices for devices such as femoral head adapters, infusion pump cassettes and fluoroscopic X‑ray systems between 24‑28 August 2026.

Balt Extrusion is voluntarily recalling certain ANRYV connector lots after bacterial endotoxin test failures; no patient harm reported.

Balt Extrusion is voluntarily recalling specific ANRYV connector lots after non‑conforming bacterial endotoxin test results, affecting standalone connectors and those in selected kits; no patient harm reported.

The MFDS will host a public‑private meeting on the 15th in Seoul to discuss regulatory and review processes for digital convergence medicines under the Digital Medical Device Act.