Philips Medical Systems (Cleveland) Inc recalls 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommo…

Recall date

January 31, 2017

Source

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

Recall number

Z-1479-2017

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Worldwide distribution. US nationwide, ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CAYMEN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, FINLAND, FRANCE, GABON, GERMANY, GREAT BRITAIN, GREECE, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL…

Why it was recalled

Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

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

What was recalled

882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).