The Recall Desk
ModerateFDA (Devices)·Z-1338-2013·Announced 2013-05-29

Philips CT Systems Recall for Incorrect CTDIVol Data Storage

Philips is recalling 515 CT systems because they stored the sum of CTDIVol values instead of individual slice values, resulting in incorrect data.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard involves incorrect data recording (CTDIVol values) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity issue involving data integrity.

Plain-English summary

Philips Medical Systems (Cleveland) Inc. is recalling 515 Computed Tomography (CT) X-ray systems, including the Brilliance CT 16-Slice Water, Brilliance CT 10-Slice Water, Brilliance CT 6-Slice Water, MX8000 IDT 16, and MX8000 IDT 10 models. The recall affects units distributed worldwide, including across the United States and numerous international markets.

The recall was initiated after a field report indicated that the systems were storing incorrect CTDIVol (Computed Tomography Dose Index Volume) information. Instead of storing the CTDIVol value for each individual slice in the DICOM tag, the systems calculated the sum of all CTDIVol values from all images in the dataset and stored that total value. This error resulted in incorrect dose information being recorded in the system's data tags.

Healthcare facilities and users of these systems should contact Philips Medical Systems for further instructions on how to correct the data storage issue. The affected units are identified by specific system codes and serial numbers listed in the official recall documentation.

The recalled product

Product
Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Phil
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography (CT) Systems
Hazard
Affected units
515

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)

  • System Code #728255
  • Serial #: 9702
  • 9703
  • 9704
  • 9705
  • 9706
  • 9707
  • 9709
  • 9710
  • 9713
  • 9714
  • 9717
  • 9718
  • 9719
  • 9721
  • 9722
  • 9723
  • 9724
  • 9725
  • 9727

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

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