FDAFDA · Food and drugs·Recall number Z-2255-2012
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Published September 19, 2012 · Recall initiated: July 10, 2012
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
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide Distribution -- USA (nationwide) Distribution
- Lot
- Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States