Philips Medical Systems (Cleveland) Inc recalls BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging

Recall date

May 25, 2016

Source

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

Recall number

Z-2735-2016

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

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, N…

Why it was 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.

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 X, model #882478; gamma camera designed for single or dual detector nuclear imaging