Z-0522-2018 Class II Terminated
FDA device recall Z-0522-2018 was initiated by Philips Medical Systems (Cleveland) Inc on November 1, 2017 and is designated Class II. 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. The recall status is terminated (terminated August 14, 2018). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- November 1, 2017
- Termination Date
- August 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
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.
Distribution Pattern
One domestic and 1 foreign consignee ( Spain)
Code Information
Ingenuity TF PET/CT Model # 882442