Spacelabs Healthcare, Llc: Medical Device Recall in 2014 - (Recall #: Z-1273-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 14, 2014

Date Posted: April 2, 2014

Recall Number: Z-1273-2014

Event ID: 67638

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.

Status: Terminated

Product Quantity: 36 units total: 17 units were distributed in the US and 19 units distributed outside the US.

Code Information:

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".

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.

Voluntary or Mandated:

Voluntary: Firm initiated