HeartSine Technologies, LTD tilbagetrækker specifikke serienumre af HeartSine samaritan® PAD devices

Denne meddelelse indeholder information om tilbagetrækning af udstyret. Læs mere i meddelelsen fra fabrikanten.

Referencer

• Produkt: HeartSine samaritan® PAD devices 
• Fabrikant: HeartSine Technologies, LTD
• Fabrikantens referencenummer: RA2026-4257283 (FA334)
• Lægemiddelstyrelsens sagsnummer: 2026091630

Letter A – Customers impacted by all three field actions (FA318 / FA319 / FA334) and have responded to FA318 (T3)

Letter B – Customers impacted by all three field actions (FA318 / FA319 / FA334) and have not responded to FA318 (T3)

Letter E –Customers impacted by FA318 (T3) and FA334 (missing maintenance insert) and have responded to FA318 (T3)

Letter F –Customers impacted by FA318 (T3) and FA334 (missing maintenance insert) and have not responded to FA318 (T3)

Letter G – Customers impacted by FA319 (damaged membrane tail) + FA334 (missing maintenance insert)

Letter I – Customers impacted by FA334 (missing maintenance insert) only