The Recall Desk
HighFDA (Devices)·Z-2457-2024·Announced 2024-08-07

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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with no reported injuries or hospitalizations. The defect constitutes a risk-of-harm product (critical patient care device) where potential for serious harm exists through loss of safety alarms, but injury remains unreported and the hazard is theoretical.

Plain-English summary

Medivance Inc. is recalling Arctic Sun Temperature Management Systems (STAT and 5000 series) worldwide due to a software defect affecting approximately 10,507 units. The affected devices are distributed in the United States and internationally.

The defect causes the system to potentially fail to reach its target water temperature while operating in patient control mode, particularly during sudden patient temperature changes, water flow interruptions, or when air flow becomes blocked by obstructions or dirty filters. The critical safety issue is that the system may not generate an alarm when this failure occurs.

Without these critical alarms, clinicians may be unaware that the device is not maintaining proper patient temperature management, potentially leading to hypothermia or hyperthermia. Patients using these devices may be at risk of serious temperature regulation complications.

Medivance will release a software update to address this issue. Healthcare facilities currently using these devices should monitor for the availability of this update and apply it as soon as possible.

The recalled product

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
Manufacturer
Medivance Inc.
Category
Medical Device — Temperature Management
Hazard
  • temperature-control-failure
  • alarm-failure
  • hypothermia-risk
  • hyperthermia-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • REF/UDI-DI/Software: 6000-00-00/00801741161513/v1.0.5 and prior
  • 6000-00-00L/00801741161520/v1.0.5 and prior
  • 600001/00801741226380/v2.1.1.0 and prior
  • 600006/00801741226397/v2.1.1.0 and prior
  • 600020/00801741226403/v2.1.1.0 and prior
  • 5000-00-00/00801741080142/v3.0.2 and prior
  • 5000-00-00E/00801741127755/v3.0.2 and prior
  • 5000-00-00L/00801741080159/v3.0.2 and prior
  • 5000-1-01/00801741186134/v3.0.2 and prior
  • 5000-01-01L/00801741186141/v3.0.2 and prior
  • 5000-01-02/00801741170003/v3.0.2 and prior
  • 5000-01-03/00801741222818/v3.0.2 and prior
  • 5000-01-04/00801741144653/v4.0.0 and prior
  • 5000-01-05/00801741222825/v3.0.2 and prior
  • 5000-01-07/00801741222832/v3.0.2 and prior
  • 5000-01-08/00801741222849/v3.0.2 and prior All serial numbers.

Distribution

Distributed nationwide across the United States.

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