Reported Feb 19, 2014 · Terminated

GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

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?

  • GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Lot codes and dates
    • Model #882476
    • Serial #'s: 9004
    • 9005
    • 9006
    • 9008
    • 9009
    • 9010
    • 9011
    • 9012
    • 9013
    • 9014
    • 9015
    • 9016
    • 9017
    • 9018
    • 9019
    • 9020
    • 9021
    • 9022
    • 9023
    • 9201
    • 9202
    • 9203
    • 9204
    • 9205
    • 9206
    • 9207
    • 9208
    • 9209
    • 9210
    • 9211
    • 9213
    • 9214
    • 9215
    • 9216
    • 9217
    • 9218
    • 9219
    • 9220
    • 9221
    • 9222
    • 9223
    • 9224
    • 9225
    • 9226
    • 9228
    • 9229
    • 9231
Amount recalled
47 Units

Where it was sold

Why it was recalled

The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.

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 Aug 25, 2015 · Data as of Sep 19, 5:31 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.