Z-0072-2018Class I

Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G...

Name: Z-0072-2018 Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G...
Creator: Spacelabs Healthcare, Ltd.
Published: 2017-10-11
License: https://open.fda.gov/license/

GE Healthcare / initiated 2017-10-11 / Terminated / root cause: software

FDA source

Spacelabs Healthcare, Ltd. began a recall of Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is... on 2017-10-11. FDA classified it as Class I and gives the reason as "Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0072-2018
Classification: Class I
Status: Terminated
Initiated: 2017-10-11
Posted: 2017-11-21
Terminated: 2018-03-12
Recalling firm: GE Healthcare
Product: Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. 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
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms.
Root cause tag: software
FDA root cause: Software design
Action: Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated October 24, 2017. The letter identified the affected product problem and actions to be taken. For questions call 1-800-522-7025 and select 4 for Technical Support.
Quantity in commerce: 110 units
Distribution: Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.
Product codes and lots: UDI: 10841522100017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0072-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0072-2018	Class I	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-21

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)