12 results
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40ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
FDA Recall
Completed
·Philips Ultrasound Inc·Product code IYO·August 6, 2021
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
FDA Recall
Completed
·Philips Ultrasound, Inc.·Product code ITX·June 30, 2023
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
FDA Recall
Completed
·Philips Ultrasound Inc·Product code IYN·July 22, 2021
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
FDA Recall
Completed
·Philips Ultrasound, Inc.·Product code IYN·October 9, 2023
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
FDA Recall
Completed
·Philips Ultrasound, Inc.·Product code IYN·October 9, 2023
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
FDA Recall
Completed
·Philips Ultrasound Inc·Product code IYO·August 6, 2021
Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
FDA Enforcement
Class II
·Completed·Philips Ultrasound Inc·September 29, 2021
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
FDA Enforcement
Class II
·Completed·Philips Ultrasound Inc·September 29, 2021
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
FDA Enforcement
Class II
·Completed·Philips Ultrasound, Inc.·September 13, 2023
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
FDA Enforcement
Class II
·Completed·Philips Ultrasound Inc·August 25, 2021
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
FDA Enforcement
Class II
·Completed·Philips Ultrasound, Inc.·November 15, 2023
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
FDA Enforcement
Class II
·Completed·Philips Ultrasound, Inc.·November 15, 2023