The Recall Desk
ModerateFDA (Devices)·Z-1480-2017·Announced 2017-03-22

Philips BrightView Nuclear Imaging Systems Recalled for Motion and Software Issues

Philips Medical Systems is recalling 1,218 BrightView nuclear imaging systems worldwide due to four issues, including motion controller failures and software freezes.

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 indicates a temporary or medically reversible adverse health consequence. The issues described are functional malfunctions (scan stops, software freezes) rather than direct physical hazards like electrical shock or radiation leakage, fitting the Moderate category for low-risk operational defects.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 1,218 units of the BrightView nuclear imaging system, catalog number 882480. The 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 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.

No specific dates or lot numbers are provided in the source text. Affected users should contact Philips Medical Systems for further instructions on resolving these issues.

The recalled product

Product
882480: BrightView 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 SPECT (circular and noncircular)studies
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)

  • 4000201
  • 40007030003
  • 40007060006
  • 4000586
  • 4000327
  • 4000307
  • 4000361
  • 4000146
  • 4000159
  • 4000077
  • 4000050
  • 4000687
  • 4000325
  • 4000165
  • 4000252
  • 4000315
  • 4000191
  • 4000598
  • 4000141
  • 4000565

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 →