{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Hamburg", "state": "N/A", "country": "Germany", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "81310", "recalling_firm": "Philips Medical Systems Gmbh, DMC", "address_1": "Development And Manufacturing Ctr.", "address_2": "Rontgenstr. 24", "postal_code": "N/A", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "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", "recall_number": "Z-0239-2019", "product_description": "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.", "product_quantity": "829 units", "reason_for_recall": "Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline", "recall_initiation_date": "20180919", "center_classification_date": "20181024", "termination_date": "20230810", "report_date": "20181031", "code_info": "Software 4.1.x and 4.2.x Serial Numbers: 547772/SN14000040 549865/SN14000071 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