FDAFDA · Food and drugs·Recall number Z-1442-2014
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Published April 23, 2014 · Recall initiated: March 10, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Del Mar Reynolds Medical, Ltd.
- Distributor
- USA Nationwide Distribution in the states of North Carolina and South Carolina
- Lot
- 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.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United Kingdom
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