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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence."
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.
- 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
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