Philips Medical Systems (Cleveland) Inc recalls BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView X

Recalled November 6, 2013 · FDA recall Z-0089-2014 · Philips Medical Systems (Cleveland)

Hazard

Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position. · FDA Class II

Units

371 units

Sold at

Worldwide Distribution - USA including AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, NJ, ND, NE, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, and WI. Internationally to Canada, Algeria, Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Finland, France, Gabon, Germany, India, Indonesia, Ireland, Italy, Japan, Korea Republic, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.

Description

Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.

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 components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data.

Manufacturer(s)

Philips Medical Systems (Cleveland) Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →