The Recall Desk
ModerateFDA (Devices)·Z-1354-2016·Announced 2016-04-20

Philips Ingenuity Core CT Systems Recalled for Software Error

Philips is recalling 88 Ingenuity Core CT systems because a software error may prevent automatic transmission of image data to remote devices.

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 is a software error affecting data transmission rather than a direct physical injury risk, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc. is recalling 88 Ingenuity Core Computed Tomography X-ray Systems. The recall is due to a software error that may prevent the system from automatically sending all image and data series to remote devices.

The affected units were distributed worldwide, including to all 50 U.S. states, the District of Columbia, and numerous international countries. The specific model number is 728321, and the recall covers a specific list of serial numbers provided in the agency's documentation.

Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issue. This recall addresses a functional defect in data transmission rather than a direct physical hazard to patients.

The recalled product

Product
Ingenuity Core Computed Tomography X-ray Systems, 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
88

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 No. 728321
  • S/N: 31001
  • 52000
  • 52012
  • 52015
  • 52018
  • 52020
  • 52022
  • 52030
  • 52031
  • 52044
  • 52050
  • 52063
  • 310001
  • 310022
  • 310023
  • 310026
  • 310032
  • 310039
  • 310065

Distribution

Distributed in 43 states:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

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