FDA recall Z-2276-2018

Product

Ingenuity TF PET/CT 882442

Reason for recall

A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.

Distribution

The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.

Key facts

Status

Terminated

Initiation date

2018-03-28

Report date

2018-07-04

Termination date

2020-04-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cleveland, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2276-2018