Date Initiated by Firm |
January 06, 2022 |
Date Posted |
February 02, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0974-2024 |
Recall Event ID |
93737 |
510(K)Number |
K173356 K173451
|
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
Product |
Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system |
Code Information |
UDI-DI 00884838088115
Ingenia Serial number / Accessory Serial Number
45294 100029
45294 100030
|
Recalling Firm/ Manufacturer |
Philips North America 222 Jacobs St Cambridge MA 02141-2296
|
For Additional Information Contact |
Customer Care Solution Center 800-722-9377
|
Manufacturer Reason for Recall |
Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.
|
FDA Determined Cause 2 |
Device Design |
Action |
Beginning in January 2022, Philips Field Service Engineers (FSE) visited impacted customer sites to replace the magnetic castor wheels of the HA Flextrack Trolley II with non-magnetic castor wheels. All reachable systems were addressed as of August 10, 2023. |
Quantity in Commerce |
2 |
Distribution |
Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden. |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = LNH and Original Applicant = Philips Medical Systems Nederland B.V.
|