The Recall Desk
ModerateFDA (Devices)·Z-0089-2014·Announced 2013-11-06

Philips Recalls BrightView XCT Gamma Cameras Due to Latch Failure

Philips is recalling 371 BrightView XCT gamma cameras because the Flat Panel Detector may not remain securely latched in the stowed position.

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, and the hazard involves a mechanical latch failure without reported injuries or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 371 units of the BrightView XCT gamma camera. This medical device is used for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.

The recall was initiated after Philips received field reports indicating that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position. The affected units are distributed worldwide, including in the United States and numerous international locations.

Healthcare facilities and users should identify affected units by checking the model and serial numbers listed in the official recall notice. Affected model numbers include 882454 and 882482, with specific serial numbers detailed in the FDA record. Users should contact Philips Medical Systems for instructions on how to address the defect.

The recalled product

Product
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging com
Affected units
371

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)

  • 11000082
  • and 11000111. Model Number: 882482 Serial Number(s): 6000002
  • 6000003
  • 6000004A
  • 6000005
  • 6000010
  • 6000011
  • 6000012
  • 6000013
  • 6000015
  • 6000016
  • 6000017
  • 6000018
  • 6000019
  • 6000020
  • 6000022
  • 6000023
  • 6000024
  • 6000025
  • 6000026

Distribution