SpaceLabs Arkon Anesthesia Delivery System with Version recall
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Why was SpaceLabs Arkon Anesthesia Delivery System with Version recalled?
The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
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?
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.
- Product
- SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- Quantity
- 16 units distributed in the US
- Distribution
- USA Nationwide Distribution in the states of North Carolina and South Carolina
- Recall date
- April 23, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)