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Class 3 Device Recall Ingenia Ambition X |
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Date Initiated by Firm |
December 29, 2023 |
Date Posted |
January 25, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0810-2024 |
Recall Event ID |
93788 |
510(K)Number |
K193215
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Product Classification |
System, nuclear magnetic resonance spectroscopic - Product Code LNI
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Product |
Ingenia Ambition X, Model No. 782109
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Code Information |
Model No. 782109
UDI-DI 00884838098350
Serial Number 47785
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Recalling Firm/ Manufacturer |
Philips North America 222 Jacobs St Cambridge MA 02141-2296
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For Additional Information Contact |
Customer Care Solution Center 800-722-9377
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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.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
On 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 Commerce |
7 US; 16 ROW total |
Distribution |
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. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = LNI and Original Applicant = Philips Medical Systems Nederland BV
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