The Recall Desk
ModerateFDA (Devices)·Z-1355-2016·Announced 2016-04-20

Philips Ingenuity Core 128 CT Systems Recalled for Software Error

Philips is recalling 174 Ingenuity Core 128 CT systems due to a software error that 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. The hazard is a software error affecting data transmission, which is a functional defect rather than a direct physical injury risk, fitting the criteria for moderate severity.

Plain-English summary

Philips Medical Systems (Cleveland) Inc. is recalling 174 units of the Ingenuity Core 128 Computed Tomography X-ray Systems. The recall was initiated after the firm was notified of a software error in which the system may not automatically send all image and data series to remote devices.

The affected systems were distributed worldwide, including to the United States and numerous international countries. The specific model number is 728323, and the recall covers a specific list of serial numbers provided in the official notice.

Consumers and healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Ingenuity Core 128 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
174

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. 728323
  • S/N: 30016
  • 30023
  • 30151
  • 30153
  • 32000
  • 32001
  • 32008
  • 32012
  • 32042
  • 32044
  • 32057
  • 32061
  • 32065
  • 32067
  • 32068
  • 32069
  • 32076
  • 32100
  • 32106

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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