The Recall Desk
HighFDA (Devices)·Z-1479-2017·Announced 2017-03-22

Philips BrightView XCT Nuclear Imaging Systems Recalled for Four Hardware Issues

Philips Medical Systems is recalling 1,218 BrightView XCT nuclear imaging systems worldwide due to four hardware issues, including motion controller failures and door interlock problems.

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 injuries or illnesses. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 1,218 units of the BrightView XCT (model 882482) and BrightView X upgrade to XCT (model 882454) nuclear imaging systems. These devices are designed for single or dual detector nuclear imaging and various ECT studies. The recall covers units distributed worldwide, including the United States and numerous international markets.

The recall is due to four specific hardware issues: a motion controller problem that stops scans and prevents data image production; a door interlock switch problem that disables CT scans; detector contacts that touch the head holder during patient unload; and JETStream software freezing during gated planar scans.

The source text does not specify reported injuries, illnesses, or fatalities associated with these defects. Affected users should contact the manufacturer for further instructions on remediation or repair.

The recalled product

Product
882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated
Affected units
1,218

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)

  • 6000013
  • 6000025
  • 6000029
  • 6000036
  • 6000038
  • 6000045
  • 6000051
  • 6000065
  • 6000006
  • 6000070
  • 6000074
  • 6000072
  • 6000078
  • 6000081
  • 6000083
  • 6000084
  • 6000086
  • 6000090
  • 6000113
  • 6000127

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 →