Philips Medical Systems (Cleveland) Inc recalls Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisiti…

Recall date

December 15, 2017

Source

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

Recall number

Z-0513-2018

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Worldwide Distribution - US Nationwide

Why it was recalled

During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

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

What was recalled

Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.