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Health Canada Medical devices

RENASYS™ EDGE Negative Pressure Wound Therapy

Issued October 23, 2024
Issue
Smith & Nephew Medical Ltd., has initiated a field action to voluntarily correct RENASYS™ EDGE devices. If the batteries are not appropriately maintained and charged as defined in the IFU (left in storage in an uncharged state), the battery may become depleted and be unable to recharge. The RENASYS™ EDGE device will operate on mains power and deliver therapy as intended. The device will show the charger is connected but will not increase battery charge percentage. Recall start date: October 2, 2024
Hazard description
Performance
Product
Product name
RENASYS™ EDGE Negative Pressure Wound Therapy
Reference
ID
RA-76381