BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Reported: September 14, 2016 Initiated: May 25, 2016 #Z-2736-2016
Product Description
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Reason for Recall
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.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 424 units
- Distribution
- 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.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT). Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 424 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2016. Severity: Moderate. Recall number: Z-2736-2016.
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