FDA recall Z-0725-2024

Product

Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

Reason for recall

Multiple software issues that affect device functionality.

Distribution

Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Panama, Palestine, Portugal, South Korea, Spain, Switzerland, Thailand, United Kingdom.

Key facts

Status

Ongoing

Initiation date

2023-11-30

Report date

2024-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0725-2024