Philips Medical Systems Gmbh, DMC recalls Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712…

Recall date

September 19, 2018

Source

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

Recall number

Z-0239-2019

FDA classification

Class II

Brand / firm

Philips Medical Systems Gmbh, DMC

Sold / distributed

Worldwide distribution - US Nationwide and countries of Canada Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Chile China Colombia Czech Republic Denmark Egypt Finland France French Guiana Germany Guadeloupe Hong Kong Hungary India Indonesia Iran Israel Italy Japan Jordan Korea, Repu…

Why it was recalled

Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline

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

What was recalled

Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.