The Recall Desk
HighFDA (Devices)·Z-0693-2017·Announced 2016-12-14

Philips Brilliance 64 CT Systems Recalled for Software Error

Philips Medical Systems is recalling 184 Brilliance 64 CT systems worldwide due to a software error involving the filament on timer.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 184 units of the Brilliance 64 728231 Computed Tomography 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 due to a software error associated with the filament on timer.

The affected units were distributed worldwide, including in the United States and numerous international locations. The specific distribution pattern includes the US and countries such as Australia, Brazil, Canada, China, Germany, Japan, and the United Kingdom.

Consumers and healthcare facilities should contact Philips Medical Systems for further instructions regarding the recall and potential corrective actions.

The recalled product

Product
Brilliance 64 728231 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 — Computed Tomography
Hazard
Affected units
184

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)

  • 4001
  • 4016
  • 9056
  • 9071
  • 9074
  • 9099
  • 9112
  • 9134
  • 9194
  • 9251
  • 9280
  • 9367
  • 9515
  • 9529
  • 9538
  • 9541
  • 9548
  • 9549
  • 9554
  • 9559

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 →