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.
FDA Recall Z-1273-2014 · Posted 2014-03-25
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Recalling FirmSpacelabs Healthcare, Llc
Recall StatusTerminated
Product CodeDQK
Date Initiated2014-02-14
Date Terminated2014-05-20
Product Quantity36 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.
Firm Action
Spacelabs Healthcare began sending out the Medical Device Correction letter, dated 28 February 2014, to domestic customers on 28 February 2014 and to international customers by 7 March 2014. The letter identified the product, the product, the problem, and the action to be taken by the customer. Customers are also directed to call 1-800-522-7025 and select 2 for Technical Support.
Customers are advised to dispose the CD, PN: 063-1829-11 Rev A previously supplied and replace it with the replacement CD (Rev B) provided.
Root Cause
Labeling Change Control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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