FDA recall Z-1054-2024

Product

Spectral CT on Rails: Software Version 5.1.0.X, model 728334.

Reason for recall

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

Distribution

Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.

Key facts

Status

Ongoing

Initiation date

2023-12-13

Report date

2024-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1054-2024