Recall StatusOpen, Classified
Date Initiated2024-05-03
Product Quantity590 units
Reason for Recall
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
Firm Action
Philips NA issued URGENT Medical Device Correction letter to US consigneess dated May 3, 2024 via FedEx. Philips Markets Organizations are responsible for distributing the letters outside of the US.
Letter states reason for recall, health risk and action to take:
A. If you see hydraulic fluid (oil) leakage:
" First remove fluid from the floor using a paper towel. Then remove any remaining oil film
from the floor using a cleaning agent (e.g. soap and water) and paper towel.
" Contact your local Philips service representative.
B. You may continue to use your HA FlexTrak Trolley in accordance with the intended use.
C. Circulate this notice to all users of this device so that they are aware of the issue and
associated hazard/harm until this issue has been resolved.
D. Please post this letter near the associated MR system(s) for ease of reference.
E. Complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the URGENT Medical Device Correction, understanding of the issue, and required actions to be taken.
A Philips representative will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect the HA FlexTrack Trolley and correct if required (reference FCO78100580).
If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377, 8AM-8PM EST, Monday-Friday).
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain,
Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark,
Estonia, Fiji, Finland, France, French Guiana, Germany, Guadeloupe, Honduras, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lithuania, Martinique, Mexico, Morocco,
Netherlands, Norway, Oman, Peru, Poland, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.