Recall Z-1436-2026 ยท KZF Device, Medical Examination, Ac Powered
MRIMed Inc.
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
| Date | Feb 20, 2026 (initiated Oct 13, 2025) |
| Status | Open, Classified |
| Reason | Due to battery component overheating while charging resulting in melting of internal components and causing smoke. |
| Root cause | Under Investigation by firm |
| Action | On or about 10/13/2025, the firm called customers and emailed an "URGENT MEDICAL DEVICE QUARANTINE" Letter to customer and distributers informing them that the firm has become aware of the possibility of the battery overheating during charging, resulting in melting of the internal components. Customers and Distributors are instructed to: 1. Immediately discontinue use of the battery. 2. Do not charge the battery. 3. Remove the charger from the battery. 4. Label the battery and the light as BATTERY IN QUARANTINE, DO NOT USE 5. Keep the batteries in a secure location to avoid unintended use, |
| Quantity | 314 batteries |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.