FDAFDA · Food and drugs·Recall number Z-1273-2014
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.
Published April 2, 2014 · Recall initiated: February 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Spacelabs Healthcare, Llc
- Distributor
- 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.
- Lot
- 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".
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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