—#207679

Product

HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K213583
Affected lot / code info: UDI: (01)00884838099470(21) Serial Numbers: 1538 1539 1540 1541 1542 1543 1544 1545 1546 1548 1550 1552 1553 1554 1556 1557 1558 1559 1560 1561 1563 1564 1565 1566 1567 1568 1569 1634 1635 1636 1637 1638 1639 1640 1641 1642 1643 1644 1646 1647 1648 1649 1669 1670 1672 1673 1674 1675 1676 1677 1678 1679 1680 1681 1682 101747 101749 101750 101751 101753 101754 101756 101757 101758 101759 101762 101779 101780 101781 101782 101783 101784 101785 101787 101789 101790 101791 101792 101793 101794 101795 101797 101798 101799 101800 101801 101802 101803 101804 101806 101807 101809 101810 101811 101812 101813 101814 101850 101851 SN101852

Why it was recalled

Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

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.

Timeline

Recall initiated: 2024-05-03
Posted by FDA: 2024-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207679. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.