The Recall Desk
SevereFDA (Devices)·Z-2196-2015·Announced 2015-07-29

Philips GEMINI TF 64 Slice CT/PET System Software Defect Recall

Philips is recalling 22 GEMINI TF 64 Slice CT/PET systems due to software defects that may cause incorrect tissue irradiation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury through incorrect irradiation of tissue, meeting the criteria for a Severe rating.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 22 units of the GEMINI TF 64 Slice CT/PET System. The recall involves specific serial numbers identified in the agency documentation. These systems are distributed worldwide, including in the United States, Australia, and various European and Asian countries.

The recall is initiated because Philips identified four software defects in the Tumor LOC software application. These defects may potentially result in the irradiation of healthy tissue or the non-irradiation of diseased tissue. The agency has classified this recall as Class II.

Healthcare facilities and consumers with these specific systems should contact Philips Medical Systems for further instructions on how to address the software defects.

The recalled product

Product
GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging System
Hazard
Affected units
22

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model #882471 GEMINI TF 64 Slice (453567994741)
  • Serial Number: 7007
  • 7012
  • 7042
  • 7055
  • 7083
  • 7103
  • 7116
  • 7126
  • 7132
  • 7158
  • 7160
  • 7164
  • 7169
  • 7175
  • 7179
  • 7218
  • 7221
  • 7229
  • 7245

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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