Ingenuity TF PET/CT - a integrated diagnostic X-ray recall
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Why was Ingenuity TF PET/CT - a integrated diagnostic X-ray recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Ingenuity TF PET/CT Model # 882442
- Product
- Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 2
- Distribution
- One domestic and 1 foreign consignee ( Spain)
- Recall date
- February 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)