The Recall Desk
ModerateFDA (Devices)·Z-0694-2017·Announced 2016-12-14

Philips Brilliance 64 CT Systems Recalled for Software Error

Philips Medical Systems is recalling 18 Brilliance 64 CT systems due to a software error involving the filament on timer.

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, which typically involves a situation where use of the product may cause temporary or medically reversible adverse health consequences. No specific injuries or illnesses are reported in the source text.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 18 units of the Brilliance 64 Computed Tomography (CT) X-ray systems. These devices 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 is being conducted due to a software error related to the filament on timer. The affected units were distributed worldwide, including in the United States and numerous international locations.

Healthcare facilities should contact Philips Medical Systems for instructions on how to address the software error. Consumers should not use the affected devices until the issue is resolved.

The recalled product

Product
Brilliance 64 728232 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. These devices may include signal analysis and display equipment, patient and
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
18

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 (17)

  • 122921
  • 123029
  • 123092
  • 123096
  • 123116
  • 123117
  • 123148
  • 123150
  • 123164
  • 123170
  • 123172
  • 123176
  • 123179
  • 123180
  • 123182
  • 123183
  • 123185 and 123191

Distribution

Distributed in 46 states:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Related recalls

Same manufacturer · Philips Medical Systems (Cleveland) Inc

See all →

Same hazard · software error

See all →