Reported Aug 22, 2018 · Terminated
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and…
Spacelabs Healthcare, Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spacelabs Healthcare, Ltd. · Unit B · Hertford · N/A
Is this the product you have?
- 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 room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
- Lot codes and dates
- UDI #: 10841522100017, Serial #:
328 of 328 codes
ARKN-000014ARKN-000045ARKN-000117arkn-000248ARKN-000003ARKN-000004ARKN-000012ARKN-000013ARKN-000039ARKN-000040ARKN-000044ARKN-000047ARKN-000048ARKN-000049ARKN-000259ARKN-000260ARKN-000334ARKN-000425arkn-000318arkn-000321ARKN-000120ARKN-000380ARKN-000381ARKN-000382ARKN-000383ARKN-000384ARKN-000385ARKN-000386arkn-000263arkn-000264ARKN-000288arkn-000320arkn-000231arkn-000232ARKN-000250ARKN-000251ARKN-000252ARKN-000445ARKN-000190ARKN-000191ARKN-000192ARKN-000193ARKN-000194ARKN-000208ARKN-000051ARKN-000054ARKN-000056ARKN-000057ARKN-000058ARKN-000059ARKN-000060ARKN-000061ARKN-000063ARKN-000064ARKN-000112ARKN-000114ARKN-000116ARKN-000171arkn-000242arkn-000243
- UDI #: 10841522100017, Serial #:
- Amount recalled
- 328
Where it was sold
Why it was recalled
Stop using this product now
Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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