Arkon Anesthesia Delivery System recall: Software Issue
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation…
Why was Arkon Anesthesia Delivery System recalled?
Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 10841522100017
- 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…
- Recalling firm
- Spacelabs Healthcare, Ltd.
- Quantity
- 110 units
- Distribution
- Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.
- Recall date
- November 29, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)