CLASS I Device recall · Reported 23 Apr 2014 · FDA Enforcement Report
SpaceLabs Arkon Anesthesia Delivery System recalled
Del Mar Reynolds Medical is recalling SpaceLabs Arkon Anesthesia Delivery System, distributed nationwide in the US. The recall was initiated on 10 Mar 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1442-2014
- FDA event ID
- 67781
- Recalling firm
- Del Mar Reynolds Medical, Hertford, N/A
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 10 Mar 2014
- FDA classified
- 11 Apr 2014
- Reported
- 23 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 10 Mar 2014 | Recall initiated by company | |
| 11 Apr 2014 | Classified by FDA | +32 days |
| 23 Apr 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Where it was distributed
USA Nationwide Distribution in the states of North Carolina and South Carolina
Questions about this recall
Why was it 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.
Which lots 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.
Where was it sold?
USA Nationwide Distribution in the states of North Carolina and South Carolina
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Del Mar Reynolds Medical
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Spacelabs Healthcare Arkon Anesthesia Delivery System recalled | Del Mar Reynolds Medical | Packaging Defects | 6 states |
| Device | CLASS II | Arkon Anesthesia Delivery System recalled by Del Mar Reynolds Medical | Del Mar Reynolds Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Spacelabs Pediatric Flow Sensor Kit, PN recalled | Del Mar Reynolds Medical | Labeling Errors | LA, NC, WA |
| Device | CLASS I | CAS I/II Absorbers that are parts of the BleaseSirius recalled | Del Mar Reynolds Medical | Other | Nationwide |
| Device | CLASS II | Spacelabs Arkon Anesthesia Workstation recalled | Del Mar Reynolds Medical | Device Malfunction | SC |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |