FDA recall Z-0239-2019

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-09-19

Report date

2018-10-31

Termination date

2023-08-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hamburg, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0239-2019