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Recall Observatory FDA recall evidence

Device product

BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)

Z-2736-2016

May 25, 2016

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 74894
Status
Terminated
Classification
Class II
Quantity
424 units
Official record key
device-enforcement:Z-2736-2016

Official wording

Reason: The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.

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Distribution pattern: Worldwide distribution. US nationwide, Algeria, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Finland France, Gabon, Germany, Greece, India, Indonesia, Ireland, Japan, Korea, Republic of Korea, Republic of Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software defect