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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
ADVANCED INSTRUMENTATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
ALPINION MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
ATYS
  SUBSTANTIALLY EQUIVALENT 1
BK MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 2
BUTTERFLY NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 10
CHISON MEDICAL IMAGING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CHISON MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
CLARIUS MOBILE HEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 4
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 3
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ESAOTE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
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 1
FUJIFILM HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM SONOSITE INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM SONOSITE, INC.
  SUBSTANTIALLY EQUIVALENT 6
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 14
GE MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
  SUBSTANTIALLY EQUIVALENT 4
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 13
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 2
HEALCERION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 4
HITACHI HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
HITACHI, LTD
  SUBSTANTIALLY EQUIVALENT 1
IMACOR INC
  SUBSTANTIALLY EQUIVALENT 1
INTERSON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KOELIS
  SUBSTANTIALLY EQUIVALENT 1
KOLO MEDICAL (SUZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LELTEK INC
  SUBSTANTIALLY EQUIVALENT 2
LINKQUEST INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISONO, LLC
  SUBSTANTIALLY EQUIVALENT 2
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 2
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS ULTRASOUND LLC
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 8
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 28
SENO MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI)
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 25
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
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 HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHINEERS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 8
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 9
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GROUP
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SONOSCANNER
  SUBSTANTIALLY EQUIVALENT 2
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 11
SUPERSONIC IMAGINE
  SUBSTANTIALLY EQUIVALENT 6
TELEMED
  SUBSTANTIALLY EQUIVALENT 2
TERATECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TISSUE DIFFERENTIATION INTELLIGENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
VENTRIPOINT DIAGNOSTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIASONIX LTD.
  SUBSTANTIALLY EQUIVALENT 3
VINNO TECHNOLOGY (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WINPROBE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WUHAN ZONCARE BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 146 146
2018 82 82
2019 59 59
2020 67 67
2021 213 213
2022 137 137

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 148 148
No Display/Image 52 52
Patient Data Problem 48 48
Device Operational Issue 46 46
Adverse Event Without Identified Device or Use Problem 34 34
Mechanical Jam 28 28
Output Problem 28 28
Loss of Data 25 25
Application Program Freezes, Becomes Nonfunctional 19 19
Device Displays Incorrect Message 16 16
Detachment of Device or Device Component 15 15
Display or Visual Feedback Problem 15 15
Fire 15 15
Poor Quality Image 15 15
Signal Artifact/Noise 14 14
Use of Device Problem 14 14
Computer Software Problem 13 13
Unexpected Shutdown 13 13
No Device Output 12 12
Smoking 10 10
Unintended Application Program Shut Down 9 9
Data Problem 9 9
Incorrect, Inadequate or Imprecise Resultor Readings 8 8
Computer Operating System Problem 8 8
Battery Problem 8 8
Device Dislodged or Dislocated 8 8
Improper Device Output 8 8
Incorrect Measurement 8 8
Failure to Power Up 7 7
Operating System Becomes Nonfunctional 7 7
Power Problem 6 6
Insufficient Information 6 6
Temperature Problem 6 6
No Visual Prompts/Feedback 6 6
Visual Prompts will not Clear 6 6
Device Operates Differently Than Expected 6 6
Image Display Error/Artifact 6 6
Arcing 5 5
Appropriate Term/Code Not Available 5 5
Improper or Incorrect Procedure or Method 4 4
Inadequate User Interface 4 4
Sparking 4 4
Computer System Security Problem 4 4
Overheating of Device 4 4
Loss of Power 4 4
Erratic or Intermittent Display 4 4
Thermal Decomposition of Device 4 4
Circuit Failure 3 3
Electrical /Electronic Property Problem 3 3
Device Emits Odor 3 3
Therapeutic or Diagnostic Output Failure 3 3
Noise, Audible 3 3
Intermittent Loss of Power 3 3
Activation Failure 2 2
Device Fell 2 2
Complete Loss of Power 2 2
Unintended Movement 2 2
Reset Problem 2 2
Physical Property Issue 2 2
Mechanical Problem 2 2
Image Orientation Incorrect 2 2
Failure to Run on Battery 2 2
Display Difficult to Read 2 2
Break 2 2
Application Program Problem 2 2
Flare or Flash 2 2
Electrical Overstress 2 2
Device Stops Intermittently 2 2
Device Inoperable 2 2
Incorrect Software Programming Calculations 2 2
Failure to Advance 2 2
Device Issue 2 2
Structural Problem 1 1
Failure to Align 1 1
Defective Component 1 1
Fumes or Vapors 1 1
Difficult or Delayed Activation 1 1
Defective Device 1 1
Failure to Transmit Record 1 1
Material Separation 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Electronic Property Issue 1 1
Fail-Safe Problem 1 1
Issue With Displayed Error Message 1 1
Charging Problem 1 1
Connection Problem 1 1
Device Markings/Labelling Problem 1 1
No Audible Alarm 1 1
Loss of or Failure to Bond 1 1
Use of Incorrect Control Settings 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Positioning Failure 1 1
Burst Container or Vessel 1 1
Electromagnetic Interference 1 1
Output above Specifications 1 1
Application Program Problem: Parameter Calculation Error 1 1
Peeled/Delaminated 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 325 325
No Consequences Or Impact To Patient 167 167
No Known Impact Or Consequence To Patient 109 109
Insufficient Information 41 41
Perforation 22 22
No Information 20 20
No Patient Involvement 12 12
No Code Available 11 11
Death 7 7
Hemorrhage/Bleeding 6 6
Not Applicable 6 6
Injury 5 5
Perforation of Vessels 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hyperextension 2 2
Missing Value Reason 2 2
Pregnancy 2 2
Patient Problem/Medical Problem 2 2
Laceration(s) of Esophagus 2 2
Necrosis 2 2
Pain 2 2
Laceration(s) 2 2
Misdiagnosis 2 2
Breast Cancer 2 2
Congenital Defect/Deformity 2 2
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Erythema 1 1
Flatus 1 1
Headache 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Seizures 1 1
Septic Shock 1 1
Shock 1 1
Thrombosis 1 1
Thrombus 1 1
Tingling 1 1
Cramp(s) 1 1
Dizziness 1 1
Sedation 1 1
Rupture 1 1
Distress 1 1
Mitral Insufficiency 1 1
Muscle Weakness 1 1
Insufficiency, Valvular 1 1
Burning Sensation 1 1
Perforation of Esophagus 1 1
Neck Pain 1 1
Burn, Thermal 1 1
Electric Shock 1 1
Abdominal Distention 1 1
Constipation 1 1
Unspecified Hepatic or Biliary Problem 1 1
Unspecified Tissue Injury 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 Carestream Health Inc II Jan-19-2017
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 Healthcare, LLC II Apr-11-2017
14 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Sep-06-2018
15 Hitachi Aloka Medical, Ltd. II Mar-29-2017
16 Hitachi Healthcare Americas Corporation II Aug-16-2021
17 Hitachi Medical Systems America Inc II Mar-19-2021
18 Hitachi Medical Systems America Inc II May-12-2017
19 Konica Minolta Medical Imaging USA, Inc. II Mar-27-2018
20 Konica Minolta, Inc. II Jul-26-2017
21 Mindray DS USA, Inc. dba Mindray North America II Feb-05-2020
22 NeuroLogica Corporation II Aug-14-2019
23 Olympus Corporation of the Americas II Nov-27-2020
24 Olympus Corporation of the Americas II Mar-12-2019
25 Philips Ultrasound Inc II Oct-16-2021
26 Philips Ultrasound Inc II Oct-07-2021
27 Philips Ultrasound Inc II Aug-16-2021
28 Philips Ultrasound Inc II Feb-03-2021
29 Philips Ultrasound Inc II Feb-02-2021
30 Philips Ultrasound Inc II Jan-14-2021
31 Philips Ultrasound Inc II Aug-06-2019
32 Siemens Medical Solutions USA, Inc. II Apr-27-2022
33 Siemens Medical Solutions USA, Inc. II Mar-11-2022
34 Siemens Medical Solutions USA, Inc. II Feb-03-2022
35 Siemens Medical Solutions USA, Inc. II Sep-14-2021
36 Siemens Medical Solutions USA, Inc. II Apr-01-2021
37 Siemens Medical Solutions USA, Inc. II Aug-22-2019
38 Siemens Medical Solutions USA, Inc. II Mar-26-2018
39 Siemens Medical Solutions USA, Inc. II Mar-15-2018
40 Siemens Medical Solutions USA, Inc. II Apr-24-2017
41 Toshiba American Medical Systems Inc II Jun-29-2018
42 Toshiba American Medical Systems Inc II Jul-10-2017
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