The Recall Desk
HighFDA (Devices)·Z-1481-2013·Announced 2013-06-12

Philips Recalls BrightView SPECT Gamma Cameras Due to Mechanical Failure

Philips Medical Systems is recalling 505 BrightView SPECT gamma cameras worldwide after a report of unexpected detector motion caused by a mechanical assembly failure.

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 hazard involves a mechanical failure causing unexpected motion of a medical imaging detector, which poses a risk of harm to patients or operators, but no injuries or deaths are reported in the source text.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 505 units of the BrightView SPECT gamma camera for Emission Computed Tomography. The recall is being conducted due to a report from the field indicating that the detector experienced unexpected motion resulting from a failure of the mechanical assembly.

The affected devices are distributed worldwide, including in the United States and numerous international markets. The specific units are identified by Model # 882480 and a specific list of serial numbers provided in the official recall documentation.

Healthcare facilities and users should stop using the affected BrightView SPECT gamma cameras and contact Philips Medical Systems for instructions on how to proceed with the recall and any necessary repairs or replacements.

The recalled product

Product
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed To
Affected units
505

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: 400054
  • 400381
  • 4000089
  • 4000090
  • 4000091
  • 4000093
  • 4000094
  • 4000095
  • 4000098
  • 4000099
  • 4000100
  • 4000102
  • 4000103
  • 4000104
  • 4000105
  • 4000106
  • 4000107
  • 4000108
  • 4000109

Distribution