FDA Device recall Z-2589-2018
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999
- FDA Device
- Class I
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class I recall of Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999 by Spacelabs Healthcare, citing arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2589-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-07-11 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Spacelabs Healthcare |
| Distribution | US |
Product
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
Reason
Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
Identifiers
| code_info | UDI #: 10841522100017, Serial #: ARKN-000014 ARKN-000045 ARKN-000117 arkn-000248 ARKN-000003 ARKN-000004 ARKN-00…UDI #: 10841522100017, Serial #: ARKN-000014 ARKN-000045 ARKN-000117 arkn-000248 ARKN-000003 ARKN-000004 ARKN-000012 ARKN-000013 ARKN-000039 ARKN-000040 ARKN-000044 ARKN-000047 ARKN-000048 ARKN-000049 ARKN-000259 ARKN-000260 ARKN-000334 ARKN-000425 arkn-000318 arkn-000321 ARKN-000120 ARKN-000380 ARKN-000381 ARKN-000382 ARKN-000383 ARKN-000384 ARKN-000385 ARKN-000386 arkn-000263 arkn-000264 ARKN-000288 arkn-000320 arkn-000231 arkn-000232 ARKN-000250 ARKN-000251 ARKN-000252 ARKN-000445 ARKN-000190 ARKN-000191 ARKN-000192 ARKN-000193 ARKN-000194 ARKN-000208 ARKN-000051 ARKN-000054 ARKN-000056 ARKN-000057 ARKN-000058 ARKN-000059 ARKN-000060 ARKN-000061 ARKN-000063 ARKN-000064 ARKN-000112 ARKN-000114 ARKN-000116 ARKN-000171 arkn-000242 arkn-000243 arkn-000244 ARKN-000062 ARKN-000071 ARKN-000072 ARKN-000073 ARKN-000074 ARKN-000075 ARKN-000076 ARKN-000077 ARKN-000078 ARKN-000037 ARKN-000066 ARKN-000067 ARKN-000132 ARKN |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2589-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.