FDAFDA · Food and drugs·Recall number Z-0815-2022
Revolution Apex, Revolution CT with Apex Edition
Published April 13, 2022 · Recall initiated: June 30, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- Revolution Apex, Revolution CT with Apex Edition
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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