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