FDA Device recall Z-2093-2017
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room
- FDA Device
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room by Del Mar Reynolds Medical, citing reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2093-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-14 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Del Mar Reynolds Medical |
| Distribution | FL, LA, MS, NC, SC, WY |
Product
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.
Reason
Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.
Identifiers
| code_info | *********the serial numbers and part numbers of units distributed in the US ********* Absorber Adapter Assembly Serv…*********the serial numbers and part numbers of units distributed in the US ********* Absorber Adapter Assembly Service Kit part number: 050-9045-00. Devices serial numbers: ARKN-000395, ARKN-000396, ARKN-000397, ARKN-000398, ARKN-000399, ARKN-000400, ARKN-000401, ARKN-000402, ARKN-000403, ARKN-000404, ARKN-000405, ARKN-000406, ARKN-000407, ARKN-000408, ARKN-000409, ARKN-000410, ARKN-000411, ARKN-000412, and ARKN-000413. *********the serial numbers of units distributed international ************************** ARKN-000375, ARKN-000414, ARKN-000415, ARKN-000416, ARKN-000417, ARKN-000418, ARKN-000419, ARKN-000420, ARKN-000421, ARKN-000422, and ARKN-000423. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Del Mar Reynolds Medical
- Arkon Anesthesia Delivery System, Model 99999
FDA Device · Class II · 2017-03-22 · Del Mar Reynolds Medical - Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00
FDA Device · Class II · 2015-04-29 · Del Mar Reynolds Medical - SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed
FDA Device · Class I · 2014-04-23 · Del Mar Reynolds Medical - CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following par…
FDA Device · Class I · 2013-11-27 · Del Mar Reynolds Medical - Spacelabs ARKON Anesthesia Workstation
FDA Device · Class II · 2013-07-31 · Del Mar Reynolds Medical
All Del Mar Reynolds Medical recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2093-2017%22
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