Spacelabs Arkon Anesthesia Workstation Recalled for Mechanical and Display Failures
Spacelabs Healthcare is recalling 110 Arkon Anesthesia Workstations due to failures in ventilation, gas delivery, and display alarms.
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 recall involves a critical medical device failure that results in the loss of life-sustaining functions (ventilation and gas delivery) and the absence of safety alarms, which constitutes a significant risk of serious injury.
Plain-English summary
Spacelabs Healthcare, Ltd. is recalling 110 units of the Arkon Anesthesia Delivery System, Model 99999, equipped with software version 2.61 and upgrade kit 050-9043-00 Rev G. The affected devices are intended for use in hospital environments and operating rooms for the controlled delivery of oxygen, air, nitrous oxide, and anesthetic vapor.
The recall is being conducted because the workstations experienced failures in mechanical ventilation, oxygen, and anesthetic gas delivery. These failures occurred concurrently with a failure of the display unit, resulting in a blank screen without audible or visible alarms. The devices were distributed nationwide to the states of New Mexico, Wyoming, Florida, North Carolina, Mississippi, Colorado, Connecticut, Maine, and Alabama.
Healthcare facilities should stop using the affected devices and contact Spacelabs Healthcare for further instructions on the recall process.
The recalled product
- Product
- Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and…
- Manufacturer
- Spacelabs Healthcare, Ltd.
- Affected units
- 110
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 (1)
- UDI: 10841522100017
Distribution
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