Z-1273-2014Class II

Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN...

Name: Z-1273-2014 Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN...
Creator: Spacelabs Healthcare, Llc
Published: 2014-02-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-02-14 / Terminated / root cause: labeling and UDI

FDA source

Spacelabs Healthcare, Llc began a recall of Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access... on 2014-02-14. FDA classified it as Class II and gives the reason as "Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Access". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1273-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-14
Posted: 2014-03-25
Terminated: 2014-05-20
Recalling firm: GE Healthcare
Product: Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Access.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Spacelabs Healthcare began sending out the Medical Device Correction letter, dated 28 February 2014, to domestic customers on 28 February 2014 and to international customers by 7 March 2014. The letter identified the product, the product, the problem, and the action to be taken by the customer. Customers are also directed to call 1-800-522-7025 and select 2 for Technical Support. Customers are advised to dispose the CD, PN: 063-1829-11 Rev A previously supplied and replace it with the replacement CD (Rev B) provided.
Quantity in commerce: 36 units total: 17 units were distributed in the US and 19 units distributed outside the US.
Distribution: Worldwide Distribution- USA (nationwide) including the states of Alabama, Florida, Georgia, Louisiana, Missouri, New York, South Carolina, Tennessee, Texas and Wyoming, and the countries of Australia, Canada, Czechoslovakia, China, Colombia, France, Great Britain, Italy, Netherlands, Poland, Saudi Arabia, and Turkey.
Product codes and lots: Two G2 Clinical Access CD part numbers are affected: PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Serial numbers distributed in the US: "040-1565-10" and "063-1829-11". Serial number distributed outside the US: "063-1829-11".

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1273-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1273-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25

Product code DQK

K110779Class IISpacelabs Smart Disclosure SystemSpacelabs Healthcare / cleared 2011-04-19

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)