The Recall Desk
ModerateFDA (Devices)·Z-1353-2016·Announced 2016-04-20

Philips Brilliance iCT SP CT Systems Recalled for Software Error

Philips is recalling 49 Brilliance iCT SP 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 involves a software error affecting data transmission, which is a functional defect without reported injuries or immediate physical harm, fitting the criteria for a moderate severity recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 49 units of the Brilliance iCT SP Computed Tomography X-ray Systems. These systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

The recall was initiated after the firm was notified of a software error. This error may cause the system to fail to automatically send all image and data series to remote devices.

The affected units were distributed worldwide, including in the United States and numerous international countries. The specific model number is 728311, and the affected serial numbers range from 200011 to 200211. Users of these systems should contact Philips Medical Systems for further instructions regarding the software issue.

The recalled product

Product
Brilliance iCT SP 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 — Imaging Equipment
Hazard
Affected units
49

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. 728311
  • S/N: 200011
  • 200013
  • 200017
  • 200022
  • 200027
  • 200030
  • 200032
  • 200038
  • 200040
  • 200047
  • 200049
  • 200051
  • 200061
  • 200063
  • 200067
  • 200068
  • 200074
  • 200088
  • 200093

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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