9 results
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6ms
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Sources: EU EUDAMED, US FDA
Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
FDA Enforcement
Class II
·Terminated·Dokitz NovoSci·November 12, 2014
Brilliance iCT SP Computed Tomography X-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015
Ingenuity CT Computed Tomography X-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015
Brilliance 64 Computed Tomography X-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015
Brilliance iCT Computed Tomography X-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015
Ingenuity Core Computed Tomography X-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015
Ingenuity Core 128 Computed Tomography X-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015
Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 ASSY-MSN, VLV ASSY DR GAS CHK BCG, Manufacturing assembly - Buy 1503-3006-000 Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected and could have been installed on Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2 Anesthesia, and Amingo devices. (Service kit part numbers: 1009-8216-000, 1503-3006-000, 1503-8102-000, 1009-8423-000, 1503-8101-000).
FDA Enforcement
Class II
·Terminated·GE Medical Systems, LLC·January 27, 2016
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025