The Recall Desk
ModerateFDA (Devices)·Z-2382-2016·Announced 2016-08-17

Philips Brilliance iCT SP CT Scanner Software Recall

Philips is recalling 57 Brilliance iCT SP CT scanners due to software issues in versions 4.1.3 and 4.1.5 that could affect equipment performance.

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 describes a performance issue without reporting specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 57 units of the Brilliance iCT SP Model No. 728311. The recall is due to software issues found in versions 4.1.3 and 4.1.5 that could affect the performance of the equipment. The product is used to produce cross-sectional images of the body.

The affected units were shipped to 43 U.S. states and numerous countries worldwide. Specific serial numbers are listed in the recall documentation. No specific injuries, illnesses, or deaths are reported in the source text.

Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issue. Consumers should not use the affected equipment until it has been serviced or replaced according to the manufacturer's guidance.

The recalled product

Product
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — CT Scanner
Hazard
Affected units
57

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)

  • Brilliance iCT SP Model No. 728311 S/N:200107
  • 200003
  • 200011
  • 200009
  • 200017
  • 200074
  • 200022
  • 200013
  • 200027
  • 200049
  • 200032
  • 200030
  • 200043
  • 200040
  • 200038
  • 200047
  • 200051
  • 200044
  • 200063
  • 200061

Distribution

Distributed in 45 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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