Reported Apr 23, 2014 · Terminated
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Del Mar Reynolds Medical, 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: Del Mar Reynolds Medical, Ltd. · 1-2 Harforde Ct., Foxholes · Hertford, N/A · N/A
Is this the product you have?
- SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
- Lot codes and dates
- SERIAL
- NUMBERS OF UNITS DISTRIBUTED IN THE US
ARKN-000011ARKN-000016ARKN-000017ARKN-000019ARKN-000020ARKN-000021ARKN-000022ARKN-000023ARKN-000024ARKN-000025ARKN-000026ARKN-000027ARKN-000028ARKN-000029ARKN-000030and ARKN-000031
- Amount recalled
- 16 units distributed in the US
Where it was sold
Why it was recalled
Stop using this product now
The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
Using this product could cause serious injury, illness or death — stop using it now.
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