Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Reported: February 14, 2018 Initiated: November 1, 2017 #Z-0522-2018
Product Description
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
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.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 2
- Distribution
- One domestic and 1 foreign consignee ( Spain)
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 2.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2018. Severity: Moderate. Recall number: Z-0522-2018.
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