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U.S. Department of Health and Human Services

Class 2 Device Recall MRI LED Mobile Exam Light Battery

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 Class 2 Device Recall MRI LED Mobile Exam Light Batterysee related information
Date Initiated by FirmOctober 13, 2025
Date PostedFebruary 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1436-2026
Recall Event ID 98127
Product Classification Device, medical examination, ac powered - Product Code KZF
ProductMRI 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
Code Information Model Number: SL-111 UDI-DI code: Pending Information Serial/Lot Numbers: 23-12-074 23-12-039 0 2006001 2006002 2006004 2006005 2006006 2006007 2006008 2006009 2006011 2006012 2006013 2006014 2006015 2006016 2006017 2006018 2006020 2006021 2006023 2006024 2006026 2006027 2006028 2006029 2006030 2006031 2006031 2006032 2006033 2006034 2006035 2006038 2006039 2006040 2006043 2204028 2204047 2206001 2206003 2206004 2206005 2206006 2206009 2206010 2206011 2206012 2206013 2206014 2206015 2206016 2206017 2206018 2206019 2206020 2206021 2206022 2206024 2206026 2206027 2206029 2206030 2206033 2206034 2206036 2206037 2206038 2206040 2206042 2206043 2206044 2206045 2206046 2206048 2206049 2206050 2206052 2206053 2206054 2206055 2206056 2206057 2206058 2206059 2206060 2206062 2206063 2206064 2206065 2206066 2206067 2206068 2206069 2206070 2206071 2206072 2206073 2206074 2206075 2206076 2206077 2206079 2206080 2206081 2206082 2206083 2206084 2206085 2206086 2206087 2206088 2206090 2206092 2206093 2206094 2206095 2206096 2206097 2206098 2206099 2206100 2301228 2311040 2311058 2312001 2312002 2312003 2312004 2312005 2312006 2312007 2312008 2312009 2312010 2312011 2312012 2312013 2312014 2312015 2312016 2312018 2312019 2312020 2312021 2312022 2312023 2312024 2312025 2312026 2312027 2312029 2312030 2312031 2312033 2312034 2312035 2312036 2312036 2312037 2312038 2312039 2312041 2312041 2312042 2312044 2312045 2312047 2312049 2312050 2312051 2312052 2312053 2312054 2312055 2312056 2312057 2312058 2312059 2312060 2312061 2312062 2312064 2312065 2312066 2312067 2312068 2312070 2312071 2312072 2312074 2312075 2312076 2312077 2312078 2312079 2312080 2312080 2312081 2312082 2312082 2312083 2312084 2312087 2312089 2312090 2504001 2504003 2504004 2504005 2504006 2504007 2504008 2504010 2504011 2504013 2504014 2504015 2504016 2504017 2504018 2504021 2504022 2504025 2504026 2504029 2504030 2504031 2504032 2504035 2504036 2504038 2504039 2504040 2504044 2504047 2504049 2504050 2504051 2504054 2504055 2504056 2504058 2504059 2504068 2504072 2504073 2504075 (The serial number for this light has been confirmed as 2006025 and was switched in the records with row 312 (Evertett clinic). 20 06 044 2006025¿(account has confirmed serial as: 2006026 - 2006026 is listed as row 311 - Prince William Med Ctr) 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2206025; 2206023 2206089 & 2206078 2206xxx 2206xxx 2206xxx 2206xxx 2206xxx 2312xxx 2312xxx 2312xxx 2312xxx 2504xxx
FEI Number 3009560891
Recalling Firm/
Manufacturer		 MRIMed Inc.
1320 Stub Rd
Petaluma CA 94954-1122
For Additional Information ContactIsabella Husary
707-762-8600
Manufacturer Reason
for Recall		Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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, and await further instructions from MRI Med. For Distributors are instructed to cease distribution of the affected products. For Questions - contact MRI Med, Inc. Monday through Friday, 8:00am-3:00pm, PST, or email sales@MRImed.com or via phone at 707-762-8600
Quantity in Commerce314 batteries
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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