Z-2093-2017Class II

Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and...

Name: Z-2093-2017 Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and...
Creator: Del Mar Reynolds Medical, Ltd.
Published: 2017-04-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2017-04-14 / Terminated / root cause: design

FDA source

Del Mar Reynolds Medical, Ltd. began a recall of Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service... on 2017-04-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2093-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-14
Posted: 2017-05-16
Terminated: 2017-10-16
Recalling firm: GE Healthcare
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.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Spacelabs sent an URGENT - MEDICAL DEVICE CORRECTION letter dated April 13, 2017, to US customers via priority service. The customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record on April 14, 2017. The letter announced that the The Arkon Anesthesia Delivery System, Model 99999, and the Absorber Adapter Assembly Kit part number 050-9045-00, and Absorber Adapter Assembly part number 650-1648-01 are being recalled. Customers are advised that The Arkon Anesthesia Delivery Systems Model 99999 with Absorber Adapter Assembly part number 650-1648-00 is NOT affected by this recall. Spacelabs Healthcare is developing a hardware upgrade to improve the robustness of the affected Absorber Adapter Assembly. A Spacelabs representative will contact consignees once the upgrade is available to schedule a convenient time to update their Arkon Anesthesia Delivery System(s) at no cost. For additional information or technical assistance, please contact: 1-800-522-7025 select 4 for Anesthesia Technical Support
Quantity in commerce: 62 total (US= 19 devices and 32 kits; International = 11 devices)
Distribution: US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.
Product codes and lots: *********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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2093-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2093-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-16

Product code BSZ

K113051Class IISpacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare / cleared 2012-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)