FDA recall Z-0522-2018

Product

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

One domestic and 1 foreign consignee ( Spain)

Key facts

Status

Terminated

Initiation date

2017-11-01

Report date

2018-02-14

Termination date

2018-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cleveland, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0522-2018