FDA recall Z-1436-2026

MRIMed Inc. · Class II · device

Product

MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light

Reason for recall

Due to battery component overheating while charging resulting in melting of internal components and causing smoke.

Distribution

Worldwide - U.S. Nationwide distribution in the states of AL, CA, PA, SC, GA, MA, TX, OH, NY, NC, IA, WA, TN, NJ, MO, LA, MN, AZ, VA, SC, KY, FL, MD, IN, AK, WI, NM, DC, RI, CT, CO, OK, DE, NE, MD, IL, NH and the countries of Germany, Canada.

Key facts

Status
Ongoing
Initiation date
2025-10-13
Report date
2026-03-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Petaluma, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1436-2026