Philips Medical Systems (Cleveland) Inc recalls BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector…

Recall date

February 24, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1750-2017

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Worldwide distribution - US including AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, WI, and WV. Internationally to Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, France, Germany, India, Israel, Italy, Japan, M…

Why it was recalled

The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).