FDAFDA · Food and drugs·Recall number Z-2583-2018
CT Goldseal Optima CT 600
Published August 8, 2018 · Recall initiated: May 24, 2018
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
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
- Lot
- Serial Number 51941YC3, System ID Number 406434660
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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