Class II — Spacelabs Healthcare, Llc
| Recalling firm | SPACELABS HEALTHCARE, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 36 units total: 17 units were distributed in the US and 19 units distributed outside the US. |
| Distribution | 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. |
| Initiated | 2014-02-14 |
| Classified | 2014-03-25 |
| Terminated | 2014-05-20 |
| Recall number | Z-1273-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Spacelabs Healthcare, Llc (Z-1273-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67638/
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