Z-1442-2014Class I

SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a...

Name: Z-1442-2014 SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a...
Creator: Del Mar Reynolds Medical, Ltd.
Published: 2014-03-10
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-03-10 / Terminated / root cause: software

FDA source

Del Mar Reynolds Medical, Ltd. began a recall of SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator on 2014-03-10. FDA classified it as Class I and gives the reason as "The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence". 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-1442-2014
Classification: Class I
Status: Terminated
Initiated: 2014-03-10
Posted: 2014-04-12
Terminated: 2014-08-20
Recalling firm: GE Healthcare
Product: SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Spacelabs Healthcare sent an Urgent Medical Device Correction letter, dated 11 March 2014, to consignees. The letter identified the product, the problem, and the actions to be taken by the customer. The letter stated that Spacelabs Field Service personnel will be contacting consignees to schedule a convenient time to install, at no cost, a software upgrade. Consignees with questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
Quantity in commerce: 16 units distributed in the US
Distribution: USA Nationwide Distribution in the states of North Carolina and South Carolina
Product codes and lots: SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US: ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1442-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1442-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-11

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)