Drug recall
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number…
FDA recall event 71432 · Class II · Philips Ultrasound, Inc.
Key facts
| Event ID | 71432 |
|---|---|
| Recall numbers | Z-1807-2015 |
| Recalling firm | Philips Ultrasound, Inc. |
| Product type | Devices |
| Products | Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study (Structured Report) to be appended to subsequent… |
| Initiation date | May 15, 2015 |
| Report date | Jun 24, 2015 |
| Termination date | Aug 8, 2016 |
| 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: