Reported Jul 4, 2018 · Terminated

Ingenuity TF PET/CT 882442

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/CT 882442
Lot codes and dates
  • UDI(01)00884838059443(21)2086
  • Serial Number2086
  • UDI(01)00884838059443(21)2099
  • Serial Number2099
  • UDI(01)00884838059443(21)2095
  • Serial Number2095
  • UDI(01)00884838059443(21)2097
  • Serial Number2097
Amount recalled
28 total

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.

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 Apr 21, 2020 · Data as of Sep 19, 5:20 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.