The Recall Desk
HighFDA (Devices)·Z-1022-2016·Announced 2016-03-09

Philips Recalls BrightView XCT Gamma Cameras Due to Mechanical Defects

Philips is recalling 427 BrightView XCT gamma cameras because the collimator may contact the patient pallet or the gantry may halt prematurely during 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 is classified as FDA Class II, and the source text describes mechanical defects (collimator contact, gantry halt) that pose a risk of harm to patients, but no injuries or illnesses have been reported.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 427 units of the BrightView XCT and BrightView XCT Upgrade gamma cameras. These devices are used for Single Proton Emission Computed Tomography. The recall was initiated after the firm discovered four issues with the BrightView Family systems.

The specific hazards identified include the collimator potentially coming into contact with the bottom edge of the patient pallet during a cardiac non-Auto Body Contouring scan using Cardiac High Resolution collimators. If this contact occurs, collision sensors are designed to pause the scan. Additionally, the gantry motion may halt prematurely during a scan. The source text does not specify the details of the other two issues mentioned.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. The source text does not report any injuries or illnesses associated with these defects. Consumers and healthcare facilities should contact Philips Medical Systems for instructions on how to address these mechanical issues.

The recalled product

Product
BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
427

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 #: 882482
  • Serial #'s: 6000016
  • 6000111
  • 6000114
  • 6000122
  • 6000002
  • 6000003
  • 6000004
  • 6000005
  • 6000006
  • 6000010
  • 6000011
  • 6000012
  • 6000013
  • 6000015
  • 6000017
  • 6000018
  • 6000019
  • 6000020
  • 6000022

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 →

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