Reported Apr 2, 2014 · Terminated
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used…
Spacelabs Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spacelabs Healthcare, Llc · 35301 Se Center St · Snoqualmie, WA · 98065-9216
Is this the product you have?
- Spacelabs Healthcare G2
- Clinical Access Mislabeled CDs for PN063-1829-11 Rev A and Update Kit
- PN040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers
- Lot codes and dates
- Two G2 Clinical
- Access CD part numbers are affectedPN: 063-1829-11 Rev A and Update Kit
- PN040-1565-10
- Serial numbers distributed in the US"040-1565-10" and "063-1829-11". Serial
- number distributed outside the US"063-1829-11"
- Amount recalled
- 36 units total: 17 units were distributed in the US and 19 units distributed outside the US.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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