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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
Regulation Description Ultrasonic pulsed doppler imaging system.
Product CodeIYN
Regulation Number 892.1550
Device Class 2


Premarket Reviews
ManufacturerDecision
ALPINION MEDICAL SYSTEMS CO. LTD
  SUBSTANTIALLY EQUIVALENT 9
BK MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 3
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
CHISON MEDICAL IMAGING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
CHISON MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
CLARIUS MOBILE HEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 4
ECHONOUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS INC
  SUBSTANTIALLY EQUIVALENT 3
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ESAOTE
  SUBSTANTIALLY EQUIVALENT 6
ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 4
ESAOTE, S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
EXACT IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 16
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 22
HEALCERION CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HITACHI, LTD.
  SUBSTANTIALLY EQUIVALENT 3
KOELIS
  SUBSTANTIALLY EQUIVALENT 2
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISONO, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEURAL ANALYTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 5
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 14
QISDA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SAMSUNG MEDISON CO., LTD
  SUBSTANTIALLY EQUIVALENT 6
SAMSUNG MEDISON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 21
SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 24
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
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
SIEMENS
  SUBSTANTIALLY EQUIVALENT 14
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 8
SIEMENS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GROUP
  SUBSTANTIALLY EQUIVALENT 2
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 12
SUPERSONIC IMAGINE
  SUBSTANTIALLY EQUIVALENT 6
TELEMED
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 7
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
VIASONIX LTD.
  SUBSTANTIALLY EQUIVALENT 3
WINPROBE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 145 145
2017 108 108
2018 79 79
2019 59 59
2020 66 66
2021 77 77

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 70 70
Unintended System Motion 60 60
Device Operates Differently Than Expected 40 40
Loss of Data 39 39
Patient Data Problem 35 35
Data Problem 28 28
No Display/Image 26 26
Device Displays Incorrect Message 24 24
Adverse Event Without Identified Device or Use Problem 20 20
Fire 13 13
Poor Quality Image 13 13
Computer Software Problem 12 12
Output Problem 12 12
Improper Device Output 11 11
Loss of Power 10 10
Computer Operating System Problem 9 9
Insufficient Information 9 9
Battery Problem 8 8
Smoking 8 8
Display or Visual Feedback Problem 8 8
Mechanical Problem 7 7
Overheating of Device 6 6
Incorrect, Inadequate or Imprecise Resultor Readings 6 6
Use of Device Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Sparking 6 6
Noise, Audible 6 6
Operating System Becomes Nonfunctional 6 6
Detachment of Device or Device Component 6 6
Device Dislodged or Dislocated 6 6
Appropriate Term/Code Not Available 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Incorrect Measurement 5 5
Failure to Power Up 5 5
Device Emits Odor 5 5
Signal Artifact/Noise 4 4
Break 4 4
Computer System Security Problem 4 4
Power Problem 4 4
Reset Problem 4 4
Temperature Problem 4 4
Therapeutic or Diagnostic Output Failure 3 3
Physical Property Issue 3 3
Inadequate User Interface 3 3
Mechanics Altered 3 3
Intermittent Loss of Power 3 3
Device Inoperable 3 3
Communication or Transmission Problem 3 3
Thermal Decomposition of Device 3 3
Circuit Failure 3 3
Electrical /Electronic Property Problem 3 3
Erratic or Intermittent Display 2 2
Crack 2 2
Melted 2 2
Image Display Error/Artifact 2 2
Incorrect Software Programming Calculations 2 2
Arcing 2 2
Malposition of Device 2 2
Application Program Problem 2 2
Failure to Align 2 2
Failure to Advance 2 2
No Device Output 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Visual Prompts will not Clear 2 2
Device Stops Intermittently 2 2
Device Issue 2 2
No Visual Prompts/Feedback 2 2
Mechanical Jam 2 2
Electrical Overstress 2 2
Flare or Flash 2 2
Unintended Movement 2 2
Device Fell 2 2
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
No Apparent Adverse Event 1 1
Scratched Material 1 1
Programming Issue 1 1
Device Markings/Labelling Problem 1 1
Electrical Power Problem 1 1
Electronic Property Issue 1 1
Fail-Safe Problem 1 1
Failure to Shut Off 1 1
Issue With Displayed Error Message 1 1
Positioning Problem 1 1
Unexpected Shutdown 1 1
Program or Algorithm Execution Problem 1 1
Activation Problem 1 1
Incorrect Or Inadequate Test Results 1 1
Inadequate Storage 1 1
Defective Component 1 1
Device Slipped 1 1
Sticking 1 1
Material Separation 1 1
Fumes or Vapors 1 1
Difficult or Delayed Activation 1 1
Defective Device 1 1
Charging Problem 1 1
Connection Problem 1 1
Failure to Transmit Record 1 1
Application Program Problem: Parameter Calculation Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 219 219
No Known Impact Or Consequence To Patient 180 180
No Clinical Signs, Symptoms or Conditions 41 41
No Information 32 32
No Patient Involvement 13 13
No Code Available 12 12
Injury 8 8
Hemorrhage/Bleeding 7 7
Death 7 7
Not Applicable 6 6
Insufficient Information 5 5
Perforation of Esophagus 4 4
Patient Problem/Medical Problem 3 3
Electric Shock 2 2
Missing Value Reason 2 2
Bruise/Contusion 2 2
Breast Cancer 2 2
Laceration(s) 2 2
Pain 2 2
Pregnancy 2 2
Hyperextension 2 2
Misdiagnosis 2 2
Burn(s) 2 2
Congenital Defect/Deformity 2 2
Erythema 1 1
Flatus 1 1
Insufficiency, Valvular 1 1
Muscle Weakness 1 1
Perforation 1 1
Septic Shock 1 1
Thrombosis 1 1
Thrombus 1 1
Perforation of Vessels 1 1
Cramp(s) 1 1
Rupture 1 1
Sedation 1 1
Neck Pain 1 1
Abdominal Distention 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Seizures 1 1
Shock 1 1
Burning Sensation 1 1
Tingling 1 1
Dizziness 1 1
Distress 1 1
Mitral Insufficiency 1 1
Laceration(s) of Esophagus 1 1
Burn, Thermal 1 1
Cardiac Arrest 1 1
Headache 1 1
Constipation 1 1
Unspecified Hepatic or Biliary Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B-K Medical A/S II Aug-03-2016
2 Butterfly Network, Inc. II Mar-17-2020
3 Butterfly Network, Inc. II Mar-17-2020
4 Carestream Health Inc II Jan-19-2017
5 Carestream Health Inc II Jul-18-2016
6 ESAOTE S.P.A II Sep-30-2020
7 ESAOTE S.P.A. II Oct-23-2018
8 ESAOTE S.P.A. II Mar-20-2018
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 Medical Systems America Inc II Mar-19-2021
17 Hitachi Medical Systems America Inc II May-12-2017
18 Konica Minolta Medical Imaging USA, Inc. II Mar-27-2018
19 Konica Minolta, Inc. II Jul-26-2017
20 Mindray DS USA, Inc. dba Mindray North America II Feb-05-2020
21 NeuroLogica Corporation II Aug-14-2019
22 Olympus Corporation of the Americas II Nov-27-2020
23 Olympus Corporation of the Americas II Mar-12-2019
24 Philips Ultrasound Inc II Feb-03-2021
25 Philips Ultrasound Inc II Feb-02-2021
26 Philips Ultrasound Inc II Jan-14-2021
27 Philips Ultrasound Inc II Aug-06-2019
28 Philips Ultrasound, Inc. II Apr-13-2016
29 Philips Ultrasound, Inc. II Jan-06-2016
30 Siemens Medical Solutions USA, Inc. II Apr-01-2021
31 Siemens Medical Solutions USA, Inc. II Aug-22-2019
32 Siemens Medical Solutions USA, Inc. II Mar-26-2018
33 Siemens Medical Solutions USA, Inc. II Mar-15-2018
34 Siemens Medical Solutions USA, Inc. II Apr-24-2017
35 Siemens Medical Solutions USA, Inc. II Nov-28-2016
36 Siemens Medical Solutions USA, Inc. II May-02-2016
37 Siemens Medical Solutions USA, Inc. II Apr-27-2016
38 Toshiba American Medical Systems Inc II Jun-29-2018
39 Toshiba American Medical Systems Inc II Jul-10-2017
40 Toshiba American Medical Systems Inc II Aug-16-2016
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