Drug recall
All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ…
FDA recall event 86992 · Class II · Philips Ultrasound Inc
Key facts
| Event ID | 86992 |
|---|---|
| Recall numbers | Z-0864-2021 |
| Recalling firm | Philips Ultrasound Inc |
| Product type | Devices |
| Products | All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s) manifest differently for… |
| Initiation date | Oct 27, 2020 |
| Report date | Jan 20, 2021 |
| Termination date | Apr 19, 2023 |
| City | Bothell |
| State | WA |
| Country | United States |
| FEI number | 3019216 |
At a glance
- 1–9 Products in this recall
- 10–99 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: