FDA Device recall Z-1442-2014
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed
- FDA Device
- Class I
- terminated
- Published 2014-04-23
On 2014-04-23 the FDA classified a Class I recall of SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed by Del Mar Reynolds Medical, citing the System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1442-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-03-10 |
| Published | 2014-04-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Del Mar Reynolds Medical |
| Distribution | US |
Product
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Reason
The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
Identifiers
| code_info | SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US: ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, AR…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1442-2014%22
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