Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
This recall has been terminated (originally issued November 1, 2017).
- Recall Initiated
- November 1, 2017
- Terminated
- August 14, 2018
- Recall Number
- Z-0522-2018
- Quantity
- 2
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
One domestic and 1 foreign consignee ( Spain)
Lot / Code Info
Ingenuity TF PET/CT Model # 882442
Root Cause
Vendor change control
Action Taken
Philips Healthcare is notifying the affected users of this issue via this Customer Information Letter and correcting via Field Change Order FC088200514.
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