Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall HA FlexTrak

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall HA FlexTraksee related information
Date Initiated by FirmMay 03, 2024
Date PostedJune 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1949-2024
Recall Event ID 94603
510(K)NumberK213583 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductHA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
Code Information 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
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information ContactCustomer Care Solution Center
800-722-9377
Manufacturer 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
FDA Determined
Cause 2		Under Investigation by firm
ActionPhilips 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).
Quantity in Commerce100 units
DistributionWorldwide 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.
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 = LNH
-
-