Fisher & Paykel Healthcare

Un dispositif médical dans la base de données

  • Modèle / numéro de série
  • Description du dispositif
    SleepStyle CPAP devices. Manufactured by Fisher & Paykel Healthcare. Specific model and lot numbers are affected. This device is used for the treatment of obstructive sleep apnoea and delivers continuous positive airway pressure (CPAP) to assist with a patient’s breathing during sleep. The device is for use by adult patients at home or in a sleep laboratory. The model numbers of affected devices are: HC23XAEK and HC23XMEK HC24XAEK and HC24XMEK HC254AEK and HC254MEK HC60XAEK and HC60XMEK (Where X is a number). The relevant LOT numbers are those up to and including 091122. The image below shows where the model and lot number are located on the device label. CPAPs manufactured with lot numbers higher than 091122 have a different power cord and are not subject to this product replacement.

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