The Recall Desk
HighFDA (Devices)·Z-1562-2024·Announced 2024-04-24

MRI Patient Support Table Floor Plate May Be Incorrectly Installed

Philips GYROSCAN T5-NT MRI systems may have an incorrectly installed patient support floor plate. Affected units should be inspected to ensure proper installation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: An incorrectly installed patient support floor plate on an MRI system poses a risk of patient harm during medical procedures, meeting the criterion for risk-of-harm products where injury has not yet been reported. The FDA Class II classification confirms the product may cause adverse health consequences.

Plain-English summary

The Philips GYROSCAN T5-NT Magnetic Resonance System (Model 78106) is subject to this recall due to a potential installation defect affecting the patient support table floor plate. Approximately 23 units worldwide are impacted.

An incorrectly installed patient support floor plate may affect the stability and safety of the system during patient examinations. This defect has been identified by the manufacturer.

If you operate an affected unit, contact Philips North America LLC to verify the installation status of your system's patient support table floor plate and arrange any necessary corrections. The recall affects healthcare facilities in the United States and over 100 other countries.

The recalled product

Product
GYROSCAN T5-NT, Magnetic Resonance System.
Manufacturer
Philips North America Llc
Hazard
  • installation-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model No. 78106
  • UDI-DI n/a
  • Serial No. 1194
  • 1249
  • 1009
  • 1161
  • 1091
  • 1130
  • 1183
  • 1196
  • 1260
  • 1151
  • 1022
  • 1126
  • 1176
  • 1211
  • 1238
  • 1256
  • 1070
  • 1233

Distribution

Distributed nationwide across the United States.