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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device system, imaging, pulsed echo, ultrasonic
Product CodeIYO
Regulation Number 892.1560
Device Class 2


Premarket Reviews
ManufacturerDecision
ADECHO TECH
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED INSTRUMENTATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVANTSONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC, (C.R. BARD, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BIIM ULTRASOUND AS
  SUBSTANTIALLY EQUIVALENT 1
BIOBOT SURGICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 2
BUTTERFLY NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DELPHINUS MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
DGH TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
DOLPHIN MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
ECHOLIGHT S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ECHONOUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ECHOSENS
  SUBSTANTIALLY EQUIVALENT 6
EDAN INSTRUMENTS INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ELLEX MEDICAL PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
EMAGINE SOLUTIONS TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXACT IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
FCU CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFRAREDX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ISONO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 2
LIGHTMED USA, INC
  SUBSTANTIALLY EQUIVALENT 1
LIGHTMED USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LILIUM OTSUKA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MCUBE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
MEDA CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
MEDNOVEL TECHNOLOGY LTD
  SUBSTANTIALLY EQUIVALENT 1
METRITRACK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NAVIFUS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS VOLCANO
  SUBSTANTIALLY EQUIVALENT 1
QISDA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QT ULTRASOUND LLC
  SUBSTANTIALLY EQUIVALENT 2
QT ULTRASOUND, LLC
  SUBSTANTIALLY EQUIVALENT 1
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
RIVANNA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONAVEX, INC
  SUBSTANTIALLY EQUIVALENT 1
SONIC INCYTES
  SUBSTANTIALLY EQUIVALENT 1
SONIVATE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU LISCHKA MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TAIHAO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
THD SPA
  SUBSTANTIALLY EQUIVALENT 2
VAVE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERATHON INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
WEIPENG (SUZHOU) MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 238 238
2018 362 362
2019 537 537
2020 498 620
2021 617 739
2022 205 205

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 554 554
Battery Problem 356 356
Loss of Power 339 339
Retraction Problem 199 199
No Apparent Adverse Event 198 198
Defective Component 180 180
Unexpected Shutdown 177 177
Application Program Freezes, Becomes Nonfunctional 112 112
Break 96 96
No Display/Image 96 96
Contamination /Decontamination Problem 87 87
Image Display Error/Artifact 73 73
Charging Problem 42 42
Premature Discharge of Battery 41 41
Data Problem 36 36
Erratic or Intermittent Display 27 27
Failure to Charge 25 25
Computer Software Problem 21 21
Display or Visual Feedback Problem 21 21
Failure to Power Up 20 20
Device Operates Differently Than Expected 20 20
Failure to Align 20 20
Device Displays Incorrect Message 19 141
Difficult or Delayed Activation 16 16
Adverse Event Without Identified Device or Use Problem 16 138
Incorrect, Inadequate or Imprecise Resultor Readings 16 16
Loss of Data 15 15
Crack 14 14
Signal Artifact/Noise 13 13
Thermal Decomposition of Device 13 13
Operating System Becomes Nonfunctional 12 12
Appropriate Term/Code Not Available 12 12
Device Sensing Problem 10 10
Malposition of Device 10 10
Imprecision 10 10
Incorrect Measurement 10 10
Therapeutic or Diagnostic Output Failure 10 10
Defective Device 9 9
Power Problem 8 8
Noise, Audible 8 8
Sharp Edges 8 8
Loose or Intermittent Connection 8 8
Failure to Read Input Signal 8 8
Fire 8 8
Electrical /Electronic Property Problem 8 8
Device Stops Intermittently 7 7
Inappropriate/Inadequate Shock/Stimulation 7 7
Output Problem 6 6
Smoking 6 6
Computer Operating System Problem 6 6
Connection Problem 5 5
Failure to Shut Off 5 5
Device Inoperable 5 5
Component Missing 5 5
Overheating of Device 5 5
Device Emits Odor 4 4
Use of Device Problem 4 4
Material Integrity Problem 4 4
Application Program Problem 4 4
Device Operational Issue 3 3
Sparking 3 3
Incorrect Or Inadequate Test Results 3 3
Compatibility Problem 3 3
Positioning Problem 3 3
Measurement System Incompatibility 3 3
Material Split, Cut or Torn 3 3
Temperature Problem 3 3
Insufficient Information 3 3
Self-Activation or Keying 3 3
Material Separation 3 3
Inaccurate Synchronization 3 3
Inadequacy of Device Shape and/or Size 3 3
No Device Output 3 3
Mechanical Problem 3 3
Failure to Run on Battery 3 3
False Reading From Device Non-Compliance 3 3
Electromagnetic Interference 3 3
Intermittent Continuity 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Delayed Program or Algorithm Execution 3 3
Intermittent Loss of Power 3 3
Charred 2 2
Material Discolored 2 2
Display Difficult to Read 2 2
Material Frayed 2 2
Image Orientation Incorrect 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Radiofrequency Interference (RFI) 2 2
Scratched Material 2 2
Device Fell 2 2
Explosion 2 2
Material Protrusion/Extrusion 2 2
Device Contamination with Chemical or Other Material 2 2
Microbial Contamination of Device 2 2
Calibration Problem 2 2
Communication or Transmission Problem 2 2
Activation, Positioning or SeparationProblem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1133 1133
No Clinical Signs, Symptoms or Conditions 860 982
No Known Impact Or Consequence To Patient 573 573
No Patient Involvement 41 41
Insufficient Information 38 38
No Information 26 26
No Code Available 6 6
Discomfort 5 5
Death 3 3
Failure of Implant 3 3
Unspecified Infection 3 3
Vascular Dissection 3 3
Cardiac Perforation 3 3
Electric Shock 3 3
Patient Problem/Medical Problem 2 2
Erythema 2 2
Pain 2 2
Complaint, Ill-Defined 2 2
Hemorrhage/Bleeding 2 2
Perforation of Vessels 2 2
Blurred Vision 1 1
Visual Impairment 1 1
Burning Sensation 1 1
Hypersensitivity/Allergic reaction 1 1
Ulcer 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Skin Inflammation 1 1
Needle Stick/Puncture 1 1
Aortic Dissection 1 1
Perforation 1 123
Rash 1 1
Local Reaction 1 1
ST Segment Elevation 1 1
Shock 1 1
Skin Irritation 1 1
Swelling 1 1
Urinary Retention 1 1
Uterine Perforation 1 1
Fistula 1 1
Angina 1 1
Burn(s) 1 1
Congenital Defect/Deformity 1 1
Infiltration into Tissue 1 1
Laceration(s) 1 1
Muscle Spasm(s) 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Eye Pain 1 1
Contact Dermatitis 1 1
Blood Loss 1 1
Complete Heart Block 1 1
Superficial (First Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Nov-23-2019
2 Civco Medical Instruments Co. Inc. II Dec-20-2021
3 ECOLAB INC III Jul-13-2018
4 GE Healthcare, LLC II Jan-24-2022
5 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Sep-06-2018
6 Parker Laboratories, Inc. II May-09-2018
7 Philips Ultrasound Inc II Sep-17-2021
8 Volcano Corp III Apr-09-2022
9 Volcano Corporation II Dec-12-2019
10 Volcano Corporation II May-17-2018
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