Spacelabs Arkon Anesthesia Delivery System Recalled for Ventilation Failure Risk
Spacelabs Healthcare is recalling 328 Arkon Anesthesia Delivery Systems because they may stop providing mechanical ventilation while in use or idle.
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 medical device that may cease mechanical ventilation, a critical life-support function. This constitutes a significant injury risk, aligning with the 'Severe' criteria for significant injury reports or high-risk device failures.
Plain-English summary
Spacelabs Healthcare, Ltd. is recalling 328 units of the Arkon Anesthesia Delivery System. The affected units are equipped with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00, and Model # 99999. These systems are intended for use in hospital environments and operating rooms to deliver oxygen, air, and nitrous oxide, and may include a ventilator.
The recall is due to a defect where the system may enter a failed state, causing mechanical ventilation to cease. This failure can occur while the machine is actively in use or while it is idle. The devices are distributed worldwide, including in the United States and various international locations.
Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. Spacelabs Healthcare is the recalling firm responsible for the corrective action. No specific instructions for consumers are provided in the source text, as the device is intended for use by qualified physicians in a hospital setting.
The recalled product
- Product
- Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating…
- Manufacturer
- Spacelabs Healthcare, Ltd.
- Hazard
- Affected units
- 328
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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