The Recall Desk
HighFDA (Devices)·Z-1442-2014·Announced 2014-04-23

SpaceLabs Arkon Anesthesia Delivery System Recalled for Software Failure

Del Mar Reynolds Medical is recalling 16 SpaceLabs Arkon Anesthesia Delivery Systems with Version 2.0 software because they may enter a controlled failed state.

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: The recall involves a medical device with a potential for functional failure (controlled failed state) where no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Del Mar Reynolds Medical, Ltd. is recalling 16 units of the SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 software installed. These systems include a ventilator and were distributed in the United States, specifically in North Carolina and South Carolina.

The recall is due to a software defect where the system may go into a controlled failed state if a specific sequence of parameters is activated on the user interface. The affected units have serial numbers ranging from ARKN-000011 to ARKN-000031.

Healthcare facilities should contact Del Mar Reynolds Medical, Ltd. for instructions on how to address the issue. The source text does not report any injuries or illnesses associated with this defect.

The recalled product

Product
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Manufacturer
Del Mar Reynolds Medical, Ltd.
Category
Medical Device — Anesthesia Delivery System
Hazard
Affected units
16

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)

  • SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US: ARKN-000011
  • ARKN-000016
  • ARKN-000017
  • ARKN-000019
  • ARKN-000020
  • ARKN-000021
  • ARKN-000022
  • ARKN-000023
  • ARKN-000024
  • ARKN-000025
  • ARKN-000026
  • ARKN-000027
  • ARKN-000028
  • ARKN-000029
  • ARKN-000030
  • and ARKN-000031.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same manufacturer · Del Mar Reynolds Medical, Ltd.

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Same hazard · software failure

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