Reported Feb 12, 2014 · Terminated

Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470,…

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?

6 of 6 products

Products covered by this recall
Model / numberProduct as published
882412TruFlight Select
882438GEMINI TF PET/CT16
882470GEMINI TF PET/CT 64
882471GEMINI TF Ready
882473& GEMINI TF Big Bore
882476)
Lot codes and dates
  • 382 of 382 codes

    • Model #882412
    • Serial #'s:14701
    • 14702
    • 14704
    • 14705
    • 14706
    • 14707
    • 14708
    • 14709
    • 14710 & 14711. Model #882438
    • Serial #'s:17002
    • 17003
    • 17004
    • 17005
    • 17006
    • 17007
    • 17008
    • 17009
    • 17010
    • 17011
    • 17012
    • 17013
    • 17014
    • 17015
    • 17017
    • 17018
    • 17019
    • 17021
    • 17022
    • 17023
    • 17024
    • 17025
    • 17026 & 17028. Model #882470
    • Serial #'s: 7003
    • 7004
    • 7005
    • 7006
    • 7008
    • 7009
    • 7010
    • 7011
    • 7014
    • 7015
    • 7017
    • 7019
    • 7020
    • 7021
    • 7022
    • 7024
    • 7025
    • 7026
    • 7031
    • 7034
    • 7035
    • 7036
    • 7039
    • 7043
    • 7045
    • 7049
    • 7050
Amount recalled
386 units

Where it was sold

Why it was recalled

The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected 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 Feb 2, 2016 · Data as of Sep 19, 5:32 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.