Z-1771-2013Class II

Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery...

Name: Z-1771-2013 Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery...
Creator: Del Mar Reynolds Medical, Ltd.
Published: 2013-06-07
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-06-07 / Terminated / root cause: software

FDA source

Del Mar Reynolds Medical, Ltd. began a recall of Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled... on 2013-06-07. FDA classified it as Class II and gives the reason as "Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a...". 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-1771-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-07
Posted: 2013-07-19
Terminated: 2013-08-29
Recalling firm: GE Healthcare
Product: Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation 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.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.
Root cause tag: software
FDA root cause: Software design
Action: Spacelabs Healthcare sent an Urgent Medical Device Correction" letter, dated June 20, 2013, to all affected consignees. The letter identified the product, th problem, and the action to be taken by the consignee. Consignees were instructed to advise their staff of the situation. Consignees were also advised that Spacelabs Field Service personnel would be contacting them at their facility to schedule installation of a software update to resolve the issue at not cost to the consignee. Consignees with questions were instructed to call Technical Support at 1-800-522-7025 and select option 2. For questions regarding this recall call 800-522-7025.
Quantity in commerce: 9 units (4 in the US and 5 outside US)
Distribution: Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.
Product codes and lots: ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1771-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1771-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-19

Product code CBK

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)