openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Code information
Model No. 781178 UDI-DI N/A Serial Number 20150; Model No. 781196 UDI-DI N/A Serial Nos. 22270 22095 21113; Model No. 781296 UDI-DI 00884838004108 Serial Nos. 33406 33547 32773 32789 32388
Distribution pattern
Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Code information
Model No. 781283 UDI-DI 00884838009806 Serial Number 39016
Distribution pattern
Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Code information
Model No. 781177 UDI-DI N/A Serial Number 17043
Distribution pattern
Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Code information
Model No. 782109 UDI-DI 00884838098350 Serial Number 47785
Distribution pattern
Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Code information
Model No. 781195 UDI-DI N/A Serial Number 18887 18972
Distribution pattern
Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
device · product 6 of 6
SmartPath to dStream for 1.5T, Model No. 781260, 782112
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Code information
Model No. 781260 UDI-DI 00884838095076 Serial Numbers 21020 9024 8657 21200 21223 18948 32131; Model No. 782112 UDI-DI 00884838098886 Serial Numbers 30089 20204
Distribution pattern
Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
