FDA recall Z-2247-2024

Product

First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

Reason for recall

Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

Distribution

Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, IL, IN, LA, MA, MD, MI, MO, MS, NC, NY, OK, PA, TN, TX, & VA. The countries of Korea & Serbia.

Key facts

Status

Ongoing

Initiation date

2024-05-09

Report date

2024-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2247-2024