The Recall Desk
ModerateFDA (Devices)·Z-1020-2016·Announced 2016-03-09

Philips Recalls BrightView Gamma Cameras Due to Motion and Collision Issues

Philips Medical Systems is recalling 677 BrightView gamma cameras because the collimator may contact the patient pallet or the gantry may halt prematurely during scans.

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, but the source text does not report any hospitalizations, injuries, or deaths. The described hazards involve mechanical pauses or halts during imaging, which aligns with the 'Moderate' criteria for low-risk issues without reported harm.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 677 units of the BrightView gamma camera, model # 882080. These devices are designed for single or dual detector nuclear imaging. The recall covers units distributed nationwide in the United States and in numerous countries worldwide.

The firm identified two specific issues with the systems. First, during a cardiac non-Auto Body Contouring (ABC) scan using Cardiac High Resolution (CHR) collimators, the collimator may come into contact with the bottom edge of the patient pallet. If this occurs, collision sensors are designed to pause the scan. Second, during a scan, the gantry motion may halt prematurely. The source text does not report any injuries, illnesses, or deaths associated with these issues.

Healthcare facilities and users should contact Philips Medical Systems for instructions on how to address these defects. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
Affected units
677

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)

  • Model # 882480
  • Serial #'s: 4000002
  • 4000002.75
  • 4000003
  • 4000004
  • 4000006
  • 4000007
  • 4000008
  • 4000009
  • 4000010
  • 4000011
  • 4000013
  • 4000030
  • 4000031
  • 4000032
  • 4000033
  • 4000034
  • 4000035
  • 4000036
  • 4000037

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

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 →