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U.S. Department of Health and Human Services

Class 3 Device Recall Achieva 1.5T

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 Class 3 Device Recall Achieva 1.5Tsee related information
Date Initiated by FirmDecember 29, 2023
Date PostedJanuary 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0807-2024
Recall Event ID 93788
510(K)NumberK193215 
Product Classification System, nuclear magnetic resonance spectroscopic - Product Code LNI
ProductAchieva 1.5T, Model No. 781178, 781196, 781296
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
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information ContactCustomer Care Solution Center
800-722-9377
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn December 29, 2023, the firm notified affected customers with URGENT Medical Device Correction letters. The firm stated there is no impact to patients or users. There is a potential risk of electrical shock for service personnel. Customers may continue to use MR systems in accordance with the intended use. Circulate this notice to all users of this device so that they are aware of the issue, and post the letter in the technical room until the electrical shock warning label is updated. A Philips representative will contact you to schedule a time for a Field Service Engineer to verify the electrical shock warning label and apply the correct label if applicable. If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in Commerce7 US; 16 ROW total
DistributionWorldwide - 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.
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.
510(K) Database510(K)s with Product Code = LNI
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