FDAFDA · Food and drugs·Recall number Z-0522-2018
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Published February 14, 2018 · Recall initiated: November 1, 2017
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
One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- One domestic and 1 foreign consignee ( Spain)
- Lot
- Ingenuity TF PET/CT Model # 882442
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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