FDAFDA · Food and drugs·Recall number Z-1492-2020
UroDiagnost Eleva, system code 708033
Published March 25, 2020 · Recall initiated: December 30, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America, LLC
- Distributor
- Nationwide domestic distribution. Foreign distribution worldwide.
- Lot
- Serial numbers 64 48 2 60
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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