The Recall Desk
HighFDA (Devices)·Z-0696-2017·Announced 2016-12-14

Philips Ingenuity Core 128 MRI Software Recall for Timer Error

Philips Medical Systems is recalling 509 Ingenuity Core 128 MRI systems due to a software error involving the filament on timer.

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: The recall is classified as FDA Class II, and the source text does not explicitly state that no injuries or illnesses have been reported, nor does it confirm that the hazard is purely theoretical. Therefore, it is scored as High (3) as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 509 units of the Ingenuity Core 128 MRI system, model 728323. The recall is due to a software error associated with the filament on timer.

The affected units were distributed worldwide, including all 50 U.S. states and numerous international locations. The source text does not specify the exact nature of the hazard or any reported injuries or illnesses associated with this software error.

Consumers and healthcare facilities should contact Philips Medical Systems for further instructions on how to address this software issue.

The recalled product

Product
Ingenuity Core 128 728323
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — MRI System
Hazard
Affected units
509

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)

  • 30016
  • 30023
  • 30024
  • 30151
  • 32000
  • 32001
  • 32008
  • 32010
  • 32012
  • 32013
  • 32015
  • 32016
  • 32018
  • 32021
  • 32022
  • 32024
  • 32026
  • 32028
  • 32032
  • 32033

Distribution

Distributed in 46 states:

Part of a larger recall action

This product is one of 5 recalled by Philips Medical Systems (Cleveland) Inc 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 5 products in this recall →

Related recalls

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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Same hazard · software error

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