Drug recall
VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be…
FDA recall event 62757 · Class III · Trek Diagnostic Systems
Key facts
| Event ID | 62757 |
|---|---|
| Recall numbers | Z-2323-2012 |
| Recalling firm | Trek Diagnostic Systems |
| Product type | Devices |
| Products | VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the… |
| Initiation date | Jul 23, 2012 |
| Report date | Sep 12, 2012 |
| Termination date | Jun 18, 2013 |
| City | Cleveland |
| State | OH |
| Country | United States |
| FEI number | 1000515493 |
At a glance
- 1–9 Products in this recall
- 1–9 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: