Device product
Achieva 1.5T, Model No. 781178, 781196, 781296
Z-0807-2024
Product summary
- Event
- Event 93788
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 7 US; 16 ROW total
- Official record key
device-enforcement:Z-0807-2024
Official wording
Reason: 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.
Derived failure modes
-
Labeling or packaging
label is missing