The Recall Desk

FDA (Devices) recall action 63822

Philips Medical Systems (Cleveland) Inc recalled 4 products on 2013-03-06

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2013-03-06
Critical
0
Units
871

Why these products were recalled

Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··2013-03-06

    Philips GEMINI PET/CT Systems Recalled for Software Data Flipping Error

    Philips is recalling 30 GEMINI PET/CT systems because a software error causes Intensity Projection data to be flipped and mislabeled left-to-right.

    Product
    Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations…
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2013-03-06

    Philips Brilliance CT Scanners Recalled for Software Data Flipping Error

    Philips is recalling Brilliance CT scanners because a software anomaly causes Intensity Projection datasets to be flipped and incorrectly labeled left-to-right.

    Product
    Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
    Category
    Distribution
    43 states
  • ModerateFDA (Devices)··2013-03-06

    Philips Medical Systems Recalls Extended Brilliance Workspace X-Ray Scanners

    Philips Medical Systems is recalling 39 Extended Brilliance Workspace X-Ray Scanners because a software anomaly may cause generated data sets to be flipped and incorrectly labeled.

    Product
    Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2013-03-06

    Philips GEMINI TF Big Bore PET/CT Systems Recalled for Software Error

    Philips is recalling 37 GEMINI TF Big Bore PET/CT systems because a software error may cause generated Intensity Projection data to be flipped and incorrectly labeled.

    Product
    Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed…
    Category
    Distribution
    43 states