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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device system, imaging, pulsed doppler, ultrasonic
Product CodeIYN
Regulation Number 892.1550
Device Class 2


Premarket Reviews
ManufacturerDecision
ACO HEALTHCARE CO,. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALPINION MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
ATYS
  SUBSTANTIALLY EQUIVALENT 1
BIONET CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BK MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 3
BUTTERFLY NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 10
CHISON MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
CLARIUS MOBILE HEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 3
COMPAL ELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRYSTALLINE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
E-SCOPICS
  SUBSTANTIALLY EQUIVALENT 1
ECHONOUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE, S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
EXACT IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACT IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXO IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM SONOSITE INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM SONOSITE, INC.
  SUBSTANTIALLY EQUIVALENT 5
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 10
GE MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND AND
  SUBSTANTIALLY EQUIVALENT 4
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 12
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
  SUBSTANTIALLY EQUIVALENT 15
GUANGDONG YOUKEY MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALCERION CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HEALCERION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 4
HITACHI HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
IMACOR INC
  SUBSTANTIALLY EQUIVALENT 1
IMSONIC MEDICAL CHINA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KOLO MEDICAL (SUZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LELTEK INC
  SUBSTANTIALLY EQUIVALENT 3
NATIONAL TAIWAN UNIVERSITY
  SUBSTANTIALLY EQUIVALENT 1
NAVIGANT CONSULTING - ON BEHALF OF ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
NEURAL ANALYTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVASIGNAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS ULTRASOUND LLC
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 7
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
QISDA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SAMSUNG MEDISON CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG MEDISON CO., LTD
  SUBSTANTIALLY EQUIVALENT 6
SAMSUNG MEDISON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 23
SENO MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI)
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 21
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO.LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHINEERS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 8
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GROUP
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SONOSCANNER
  SUBSTANTIALLY EQUIVALENT 1
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
SUPERSONIC IMAGINE
  SUBSTANTIALLY EQUIVALENT 6
TELEMED
  SUBSTANTIALLY EQUIVALENT 1
TERATECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TISSUE DIFFERENTIATION INTELLIGENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VENTRIPOINT DIAGNOSTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIASONIX LTD.
  SUBSTANTIALLY EQUIVALENT 2
VINNO TECHNOLOGY (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VINNO TECHNOLOGY (SUZHOU) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUHAN ZONCARE BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 82 82
2019 59 59
2020 67 67
2021 213 213
2022 185 185

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 159 159
No Display/Image 51 51
Patient Data Problem 50 50
Adverse Event Without Identified Device or Use Problem 35 35
Mechanical Jam 31 31
Detachment of Device or Device Component 19 19
Device Operational Issue 15 15
Loss of Data 15 15
Use of Device Problem 15 15
Poor Quality Image 15 15
Unexpected Shutdown 14 14
Application Program Freezes, Becomes Nonfunctional 14 14
No Device Output 13 13
Output Problem 12 12
Display or Visual Feedback Problem 11 11
Fire 11 11
Computer Software Problem 8 8
Image Display Error/Artifact 8 8
Smoking 8 8
Data Problem 8 8
Unintended Application Program Shut Down 7 7
Battery Problem 7 7
Operating System Becomes Nonfunctional 7 7
Device Dislodged or Dislocated 7 7
Computer Operating System Problem 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Failure to Power Up 6 6
Incorrect Measurement 6 6
Device Displays Incorrect Message 6 6
Visual Prompts will not Clear 6 6
No Visual Prompts/Feedback 6 6
Temperature Problem 6 6
Power Problem 6 6
Arcing 5 5
Inadequate User Interface 4 4
Loss of Power 4 4
Erratic or Intermittent Display 4 4
Therapeutic or Diagnostic Output Failure 4 4
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Intermittent Loss of Power 3 3
Thermal Decomposition of Device 3 3
Mechanical Problem 3 3
Device Emits Odor 3 3
Sparking 3 3
Improper or Incorrect Procedure or Method 3 3
Defective Component 2 2
Application Program Problem 2 2
Failure to Advance 2 2
Flare or Flash 2 2
Improper Device Output 2 2
Electrical Overstress 2 2
Image Orientation Incorrect 2 2
Failure to Run on Battery 2 2
Overheating of Device 2 2
Break 2 2
Circuit Failure 2 2
Display Difficult to Read 2 2
Unintended Movement 2 2
Device Fell 2 2
Complete Loss of Power 2 2
Activation Failure 2 2
Noise, Audible 2 2
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1
Reset Problem 1 1
Unintended Electrical Shock 1 1
Excessive Heating 1 1
Program or Algorithm Execution Problem 1 1
Activation Problem 1 1
Unclear Information 1 1
Material Frayed 1 1
Electromagnetic Interference 1 1
Electrical /Electronic Property Problem 1 1
False Negative Result 1 1
Use of Incorrect Control/Treatment Settings 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Burst Container or Vessel 1 1
No Audible Alarm 1 1
Loss of or Failure to Bond 1 1
Peeled/Delaminated 1 1
Failure to Transmit Record 1 1
Material Separation 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Output above Specifications 1 1
Electrical Shorting 1 1
Fail-Safe Problem 1 1
Connection Problem 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Physical Property Issue 1 1
Fumes or Vapors 1 1
Difficult or Delayed Activation 1 1
Defective Device 1 1
Device Tipped Over 1 1
Charging Problem 1 1
Device Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 343 343
No Consequences Or Impact To Patient 103 103
No Known Impact Or Consequence To Patient 89 89
Perforation 26 26
Insufficient Information 25 25
No Information 11 11
No Patient Involvement 9 9
No Code Available 8 8
Hemorrhage/Bleeding 6 6
Death 5 5
Injury 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Not Applicable 3 3
Perforation of Vessels 3 3
Pneumonia 3 3
Pneumothorax 3 3
Laceration(s) 2 2
Necrosis 2 2
Pain 2 2
Breast Cancer 2 2
Congenital Defect/Deformity 2 2
Misdiagnosis 2 2
Laceration(s) of Esophagus 2 2
Respiratory Failure 2 2
Hyperextension 2 2
Hemoptysis 2 2
Unspecified Tissue Injury 1 1
Abdominal Distention 1 1
Superficial (First Degree) Burn 1 1
Missing Value Reason 1 1
Constipation 1 1
Unspecified Heart Problem 1 1
Unspecified Hepatic or Biliary Problem 1 1
Perforation of Esophagus 1 1
Tingling 1 1
Burning Sensation 1 1
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Erythema 1 1
Flatus 1 1
Insufficiency, Valvular 1 1
Mitral Insufficiency 1 1
Muscle Weakness 1 1
Respiratory Distress 1 1
Septic Shock 1 1
Thrombosis 1 1
Thrombus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Butterfly Network, Inc. II Mar-17-2020
2 Butterfly Network, Inc. II Mar-17-2020
3 Canon Medical System, USA, INC. II Nov-08-2022
4 ESAOTE S.P.A II Sep-30-2020
5 ESAOTE S.P.A. II Oct-23-2018
6 ESAOTE S.P.A. II Mar-20-2018
7 FujiFilm Healthcare Americas Corporation II Nov-02-2021
8 FujiFilm Healthcare Americas Corporation II Nov-02-2021
9 GE Healthcare, LLC II Jul-12-2019
10 GE Healthcare, LLC II Jun-18-2019
11 GE Healthcare, LLC II Jan-30-2019
12 GE Healthcare, LLC II Dec-07-2018
13 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Sep-06-2018
14 GE Medical Systems, LLC II Dec-22-2022
15 Hitachi Healthcare Americas Corporation II Aug-16-2021
16 Hitachi Medical Systems America Inc II Mar-19-2021
17 Konica Minolta Medical Imaging USA, Inc. II Mar-27-2018
18 Mindray DS USA, Inc. dba Mindray North America II Feb-05-2020
19 NeuroLogica Corporation II Aug-14-2019
20 Olympus Corporation of the Americas II Nov-27-2020
21 Olympus Corporation of the Americas II Mar-12-2019
22 Philips Ultrasound Inc II Oct-16-2021
23 Philips Ultrasound Inc II Oct-07-2021
24 Philips Ultrasound Inc II Aug-16-2021
25 Philips Ultrasound Inc II Feb-03-2021
26 Philips Ultrasound Inc II Feb-02-2021
27 Philips Ultrasound Inc II Jan-14-2021
28 Philips Ultrasound Inc II Aug-06-2019
29 Siemens Medical Solutions USA, Inc. II Apr-27-2022
30 Siemens Medical Solutions USA, Inc. II Mar-11-2022
31 Siemens Medical Solutions USA, Inc. II Feb-03-2022
32 Siemens Medical Solutions USA, Inc. II Sep-14-2021
33 Siemens Medical Solutions USA, Inc. II Apr-01-2021
34 Siemens Medical Solutions USA, Inc. II Aug-22-2019
35 Siemens Medical Solutions USA, Inc. II Mar-26-2018
36 Siemens Medical Solutions USA, Inc. II Mar-15-2018
37 Toshiba American Medical Systems Inc II Jun-29-2018
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