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

Recalled October 31, 2018 · FDA recall Z-0239-2019 · Philips Medical Systems Gmbh, DMC

Hazard

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

Units

829 units

Sold at

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, Republic of Kuwait Kyrgyzstan Latvia Luxembourg Maldives Martinique Mexico Netherlands New Zealand Norway Panama Peru Poland Portugal Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom

Description

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

Product

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.

Manufacturer(s)

Philips Medical Systems Gmbh, DMC

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →