Reported Sep 9, 2015 · Terminated

Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems

Philips Medical Systems (Cleveland) Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131

Is this the product you have?

  • Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Lot codes and dates
  • M/N 882380
  • S/N
    • 11005
    • 11006
    • 11007
    • 11008
    • 11009
    • 11010
    • 11011
    • 11012
    • 11013
    • 11014 & 24061
Amount recalled
11

Where it was sold

Why it was recalled

Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 26, 2018 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.