Home / Recalls / Philips North America Llc / Z-1949-2024

Z-1949-2024 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

FDA device recall Z-1949-2024 was initiated by Philips North America Llc on May 3, 2024 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 100 units.

Recall Details

Product Type
Devices
Report Date
Jun 12, 2024
Initiation Date
May 3, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 units

Product Description

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

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

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.

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1949-2024
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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  • Z-3308-2026 Class II — Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2… (Aug 28, 2026)
  • Z-3312-2026 Class II — MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196… (Aug 28, 2026)
  • Z-3309-2026 Class II — Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377… (Aug 28, 2026)
  • Z-3316-2026 Class II — Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and… (Aug 28, 2026)
  • Z-3318-2026 Class II — Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1… (Aug 28, 2026)
  • Z-3317-2026 Class II — Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12… (Aug 28, 2026)

FDA data resources