FDA recall Z-1872-2024

Philips North America Llc · Class II · device

Product

Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144

Reason for recall

Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-04-15
Report date
2024-05-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1872-2024