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Philips Ultrasound, Inc FDA Recalls

111 recalls on file across devices, 0 of them Class I and 102 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Philips OMNI II TEE Ultrasound TransducerClass IIISep 5, 2025To provide clarification and labelling to define the useful
Philips L12-5 Ultrasound TransducerClass IIISep 5, 2025To provide clarification and labelling to define the useful
Philips Mini Multi TEE Ultrasound TransducerClass IIISep 5, 2025To provide clarification and labelling to define the useful
Philips C9-4 Ultrasound TransducerClass IIISep 5, 2025To provide clarification and labelling to define the useful
Philips S5-2 Ultrasound TransducerClass IIISep 5, 2025To provide clarification and labelling to define the useful
Philips X3-1 Ultrasound TransducerClass IIISep 5, 2025To provide clarification and labelling to define the useful
Philips L17-5 Ultrasound TransducerClass IIISep 5, 2025To provide clarification and labelling to define the useful
Philips 3D6-2 Ultrasound TransducerClass IIISep 5, 2025To provide clarification and labelling to define the useful
Philips OMNI III TEE Ultrasound TransducerClass IIISep 5, 2025To provide clarification and labelling to define the useful
Philips X7-2 Ultrasound TransducerClass IIISep 5, 2025To provide clarification and labelling to define the useful
Philips S4-1 Ultrasound TransducerClass IIISep 5, 2025To provide clarification and labelling to define the useful
7.5MHZ Endo Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C8-4v Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
mC12-3 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
X5-1 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C8-4v Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L12-4 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L8-4 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
S5-2 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
S4-1 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
X5-1c Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L18-5 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
S8-3 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
S4-1 Lumify Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
TRANSDUCER L12-5 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C6-2 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L12-5 38mm Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
S7-3t Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
3D9-3v Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
S3-1 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
X6-1 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
D2cwc Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
BP10-5ec Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
S9-2 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
SCNHD LA L7-4 HDI Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
OMNI II TEE Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L15-7IO TRANSDUCER Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
X7-2 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C9-2 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
eL18-4 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
mL26-8 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C9-3v Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L10-4LAP Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L15-7io Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C8-5 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C10-4ec Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
Transducer C10-3v Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
VL13-5 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
S4-2 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
S12-4 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
S7-2t Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C6-3 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C9-5ec Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
S8-3t Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
3D6-2 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C9-4v Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
Mini Multi TEE Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
V6-2 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
c5-1 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C9-4 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L12-5 50 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
V9-2 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C5-2 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
X7-2t Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L12-4 Lumify Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
D5cwc Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L9-3 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
X3-1 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C9-3io Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
OMNI III TEE Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C10-3v Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
XL14-3 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L11-3 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
D2TCD Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
X8-2t Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
X11-4t Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
mC7-2 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
C5-2 Lumify Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L17-5 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
L12-3 Transducer ProbeClass IIIJul 3, 2025To provide clarification and labelling to define the useful
Philips C5-2 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips L12-4 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips XL14-3 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips VL13-5 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips eL18-4 EMT Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips 3D9-3v Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips C9-5EC Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips L8-4 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips eL18-4 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips C5-1 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips S5-1 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips X6-1 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips X7-2t Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips L12-3 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips S7-2 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips L9-3 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips X5-1 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips V6-2 Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips S7-3t Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips X8-2t Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
Philips S8-3t Transducer.Class IIMay 28, 2025Ultrasound transducer devices were refurbished beyond their
5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and PrClass IIMar 23, 2024Ultrasound system with: 1) transesophageal echocardiography
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 7Class IIOct 9, 2023Their is the potential that diagnostic ultrasound systems op
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210Class IIOct 9, 2023Their is the potential that diagnostic ultrasound systems op
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU2Class IIJun 30, 2023Transducer, an ultrasound system accessory, consists of two
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232Class IISep 21, 2021Ultrasound system software issue can cause an EchoNavigator
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,Class IIAug 19, 2021Battery system data issue with the ultrasound system can int
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,Class IIAug 19, 2021Battery system data issue with the ultrasound system can int
Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 AffiniClass IIAug 6, 2021Due to a software defect that can intermittently cause the s
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795Class IIAug 6, 2021Due to a software defect that can intermittently cause the s
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxiClass IIJul 22, 2021Ultrasound system control panel arm swivel lock could fail,

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