The Recall Desk
ModerateFDA (Devices)·Z-2369-2016·Announced 2016-08-17

Philips Brilliance 16 CT Systems Recalled for Software Defect

Philips Medical Systems is recalling 203 Brilliance 16 CT systems due to a software defect causing intermittently slow response of the Host.

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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 203 units of the Brilliance 16 Computed Tomography X-ray systems. The recall is due to a software defect that causes an intermittently slow response of the Host.

The affected systems were distributed to numerous states across the United States and to many countries internationally. The specific serial numbers for the affected units are listed in the official recall documentation.

Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software defect. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography
Hazard
Affected units
203

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 #: 728246
  • Serial #s: 3010
  • 3017
  • 3031
  • 3040
  • 3043
  • 3070
  • 3072
  • 3085
  • 3090
  • 3117
  • 3123
  • 3149
  • 3179
  • 3216
  • 3247
  • 3293
  • 3314
  • 3324
  • 3411

Distribution

Distributed in 46 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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Same manufacturer · Philips Medical Systems (Cleveland) Inc

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