FDA recall Z-2715-2024

NeuroLogica Corporation · Class II · device

Product

GM60A. Digital Diagnostic Mobile X-Ray System.

Reason for recall

Potential for the anti-fall system of the device arm to fail.

Distribution

US Nationwide distribution in the states of AR, CT, GA, IN, KS, MA, MD, MO, MS, NC, ND, NJ, NV, OH, PA, VA, WV & DC.

Key facts

Status
Ongoing
Initiation date
2024-07-08
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2715-2024