The Recall Desk
HighFDA (Devices)·Z-1583-2024·Announced 2024-04-24

Philips MRI System Patient Support Table Installation Defect Recall

Philips recalls 25 Intera 1.5T R11 MRI systems due to potential incorrect installation of the patient support table floor plate, which may affect patient safety during device operation.

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: Class II device with a mechanical installation defect that poses a potential risk of patient injury. No illnesses or injuries have been reported in the source material. Per the rubric, this qualifies as High—a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips North America has recalled 25 units of the Intera 1.5T R11 Magnetic Resonance System (Model No. 781170) due to a potential installation defect.

The patient support table floor plate may be incorrectly installed on affected units. This defect could impact the safety and stability of the device during patient procedures.

Affected devices have been distributed worldwide. Facilities with the listed serial numbers should contact Philips for immediate inspection and corrective action. Do not operate affected systems until the floor plate installation has been verified and corrected by a qualified technician.

The recalled product

Product
Intera 1.5T R11, Magnetic Resonance System.
Manufacturer
Philips North America Llc
Category
Medical Device — MRI System
Hazard
Affected units
25

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. 781170
  • UDI-DI n/a
  • Serial No. 18070
  • 18021
  • 18025
  • 18110
  • 18019
  • 18009
  • 18055
  • 18064
  • 18095
  • 18105
  • 18002
  • 18082
  • 18083
  • 18039
  • 18108
  • 18032
  • 18071
  • 18092

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 41 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 41 products in this recall →

Related recalls

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Same hazard · installation defect

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