Drug recall
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN…
FDA recall event 67638 · Class II · Spacelabs Healthcare, Llc
Key facts
| Event ID | 67638 |
|---|---|
| Recall numbers | Z-1273-2014 |
| Recalling firm | Spacelabs Healthcare, Llc |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 14, 2014 |
| Report date | Apr 2, 2014 |
| Termination date | May 20, 2014 |
| City | Snoqualmie |
| State | WA |
| Country | United States |
| FEI number | 3023361 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: