Terminated

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.

FDA Recall Z-0239-2019 · Posted None

Recalling FirmPhilips Medical Systems Gmbh, DMC

Recall StatusTerminated

Product CodeMQB

Date Initiated2018-09-19

Date Terminated2023-08-10

Product Quantity829 units

Reason for Recall

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

Firm Action

Philips issued letter dated 9/10/18 to advise users of the problem. Philips will install a system software version upgrade in affected systems, which will eliminate this issue. A Philips Service Engineer will contact account when the Field Action Kit is available to be implemented. Should you need to communicate with Philips with regard to this program, please reference Field Change Order 71200177.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.