Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1273-2014

February 14, 2014

Class II

Product summary

Firm
Spacelabs Healthcare, Llc
Event
Event 67638
Status
Terminated
Classification
Class II
Quantity
36 units total: 17 units were distributed in the US and 19 units distributed outside the US.
Official record key
device-enforcement:Z-1273-2014

Official wording

Reason: 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.

Code information: 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".

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent