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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Detail

Product Description 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-1273-2014
Classification Class II
Code Info 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".
Product Distributed Qty 36 units total: 17 units were distributed in the US and 19 units distributed outside the US.
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.

Event Detail

Event Id 67638
Product Type Devices
Status Ongoing
Recalling Firm Spacelabs Healthcare, Llc
City Snoqualmie
State WA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-14
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.