The Recall Desk
HighFDA (Devices)·Z-2737-2016·Announced 2016-09-14

Philips BrightView XCT Upgrade Recalled for Potential Patient Contact

Philips is recalling three BrightView XCT Upgrade units due to a software defect that may cause the detector to contact patients during specific scans.

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 involves a risk-of-harm product where the detector may contact the patient, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling three units of the BrightView XCT Upgrade Model 882454. The recall is due to a software defect in the workflow setup script that may cause the detector to come into contact with the patient during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan.

The affected units were distributed worldwide, including in the United States and numerous international locations. The issue was identified by the firm during its review of the product's software workflow.

Consumers and healthcare facilities should contact Philips Medical Systems (Cleveland) Inc for further information regarding the recall and necessary corrective actions.

The recalled product

Product
BrightView XCT Upgrade Model 882454
Affected units
3

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 (3)

  • 11000021
  • 11000082
  • 11000111

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →