Arctic Sun Temperature Management System software failure may disable critical safety alarms
Arctic Sun Temperature Management Systems may fail to reach target temperature and critically fail to alert clinicians. The software defect affects approximately 10,507 units worldwide and risks hypothermia or hyperthermia.
- Product
- Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ T
- Category
- Medical Device
- Distribution
- Distributed nationwide