Company Spacelabs Healthcare, Llc.
Date of Enforcement Report:4/2/2014
Class lI:
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. Recall Number Z-1273-201
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..
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Llc., Snoqualmie WA on.2/14/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
36 units total: 17 units were distributed in the US and 19 units distributed outside the US
DISTRIBUTION
Nationwide and Internationally
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