TPLC - Total Product Life Cycle

• Device: system, imaging, pulsed doppler, ultrasonic
• Product Code: IYN
• Regulation Number: 892.1550
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACO HEALTHCARE CO,. LTD.
	SUBSTANTIALLY EQUIVALENT	1
ACO HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ALPINION MEDICAL SYSTEMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	9
ATYS
	SUBSTANTIALLY EQUIVALENT	1
BEIJING KONTED MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIONET CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BK MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	3
BUTTERFLY NETWORK, INC.
	SUBSTANTIALLY EQUIVALENT	2
CANON MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	10
CHISON MEDICAL TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
CLARIUS MOBILE HEALTH CORP.
	SUBSTANTIALLY EQUIVALENT	4
COMPAL ELECTRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CONTEC MEDICAL SYSTEMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CRYSTALLINE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
E-SCOPICS
	SUBSTANTIALLY EQUIVALENT	2
ECHONOUS, INC.
	SUBSTANTIALLY EQUIVALENT	2
EDAN INSTRUMENTS, INC
	SUBSTANTIALLY EQUIVALENT	1
EDAN INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ESAOTE S.P.A.
	SUBSTANTIALLY EQUIVALENT	3
ESAOTE, S.P.A.
	SUBSTANTIALLY EQUIVALENT	2
EXACT IMAGING INC.
	SUBSTANTIALLY EQUIVALENT	1
EXACT IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXO IMAGING INC.
	SUBSTANTIALLY EQUIVALENT	2
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM SONOSITE INC.
	SUBSTANTIALLY EQUIVALENT	2
FUJIFILM SONOSITE, INC.
	SUBSTANTIALLY EQUIVALENT	4
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	6
GE MEDICAL SYSTEM ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTIC, LLC
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
	SUBSTANTIALLY EQUIVALENT	1
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 DIAGNOSTIC,
	SUBSTANTIALLY EQUIVALENT	2
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	16
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
	SUBSTANTIALLY EQUIVALENT	15
GUANGDONG YOUKEY MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
IMACOR INC
	SUBSTANTIALLY EQUIVALENT	1
IMSONIC MEDICAL CHINA, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTERSON CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KOLO MEDICAL (SUZHOU) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
KONICA MINOLTA, INC.
	SUBSTANTIALLY EQUIVALENT	1
LELTEK INC
	SUBSTANTIALLY EQUIVALENT	3
MEDISONO
	SUBSTANTIALLY EQUIVALENT	1
NAVIGANT CONSULTING - ON BEHALF OF ESAOTE S.P.A.
	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
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS ULTRASOUND LLC
	SUBSTANTIALLY EQUIVALENT	5
PHILIPS ULTRASOUND, INC.
	SUBSTANTIALLY EQUIVALENT	4
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	3
QISDA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SAMSUNG MEDISON CO., LTD
	SUBSTANTIALLY EQUIVALENT	5
SAMSUNG MEDISON CO., LTD.
	SUBSTANTIALLY EQUIVALENT	25
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	2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	17
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	5
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS, USA, INC.
	SUBSTANTIALLY EQUIVALENT	3
SONIO
	SUBSTANTIALLY EQUIVALENT	2
SONOSCANNER
	SUBSTANTIALLY EQUIVALENT	1
SONOSCANNER SARL
	SUBSTANTIALLY EQUIVALENT	1
SONOSCAPE MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	5
SUPERSONIC IMAGINE
	SUBSTANTIALLY EQUIVALENT	4
SYNOVIS MICRO COMPANIES ALLIANCE
	SUBSTANTIALLY EQUIVALENT	1
TELEMED
	SUBSTANTIALLY EQUIVALENT	1
TERATECH CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
TISSUE DIFFERENTIATION INTELLIGENCE, LLC
	SUBSTANTIALLY EQUIVALENT	1
VIASONIX LTD.
	SUBSTANTIALLY EQUIVALENT	2
VINNO TECHNOLOGY (SUZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
VINNO TECHNOLOGY (SUZHOU) CO.,LTD
	SUBSTANTIALLY EQUIVALENT	2
VINNO TECHNOLOGY (SUZHOU) CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN ZONCARE BIO-MEDICAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	59	59
2020	67	67
2021	213	213
2022	186	186
2023	229	229
2024	122	122

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended System Motion	300	300
Adverse Event Without Identified Device or Use Problem	62	62
Patient Data Problem	59	59
Application Program Freezes, Becomes Nonfunctional	48	48
Mechanical Jam	45	45
No Display/Image	42	42
Detachment of Device or Device Component	30	30
Unexpected Shutdown	24	24
Poor Quality Image	23	23
Unintended Application Program Shut Down	20	20
Use of Device Problem	16	16
No Device Output	15	15
Fire	13	13
Data Problem	12	12
Incorrect Measurement	11	11
Failure to Power Up	11	11
Operating System Becomes Nonfunctional	11	11
Output Problem	11	11
Display or Visual Feedback Problem	10	10
Smoking	9	9
Loss of Data	8	8
Flare or Flash	7	7
Device Dislodged or Dislocated	7	7
Image Display Error/Artifact	7	7
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Computer Operating System Problem	6	6
Battery Problem	6	6
Arcing	6	6
Visual Prompts will not Clear	6	6
No Visual Prompts/Feedback	6	6
Insufficient Information	5	5
Sharp Edges	5	5
Therapeutic or Diagnostic Output Failure	5	5
Computer Software Problem	5	5
Display Difficult to Read	4	4
Mechanical Problem	4	4
Overheating of Device	4	4
Power Problem	4	4
Electrical Overstress	4	4
Inadequate User Interface	4	4
Sparking	4	4
Defective Component	3	3
Improper or Incorrect Procedure or Method	3	3
Temperature Problem	3	3
Erratic or Intermittent Display	3	3
Appropriate Term/Code Not Available	3	3
Unintended Electrical Shock	3	3
Material Split, Cut or Torn	3	3
Physical Resistance/Sticking	2	2
Activation Failure	2	2
Device Fell	2	2
Complete Loss of Power	2	2
Excessive Heating	2	2
Image Orientation Incorrect	2	2
Circuit Failure	2	2
Loose or Intermittent Connection	2	2
Material Puncture/Hole	2	2
Device Emits Odor	2	2
Failure to Run on Battery	2	2
Loss of Power	2	2
Unintended Movement	2	2
No Apparent Adverse Event	2	2
Failure to Calibrate	2	2
Structural Problem	1	1
Defective Device	1	1
Device Tipped Over	1	1
Application Program Problem	1	1
Communication or Transmission Problem	1	1
Connection Problem	1	1
Protective Measures Problem	1	1
Device Markings/Labelling Problem	1	1
Electrical Shorting	1	1
Fail-Safe Problem	1	1
Failure to Transmit Record	1	1
Material Separation	1	1
Peeled/Delaminated	1	1
Difficult to Insert	1	1
Leak/Splash	1	1
Material Frayed	1	1
Use of Incorrect Control/Treatment Settings	1	1
No Audible Alarm	1	1
Break	1	1
Electromagnetic Interference	1	1
Electrical /Electronic Property Problem	1	1
False Negative Result	1	1
Intermittent Loss of Power	1	1
Activation Problem	1	1
Failure to Clean Adequately	1	1
Unclear Information	1	1
Wrong Label	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	632	632
No Consequences Or Impact To Patient	69	69
No Known Impact Or Consequence To Patient	68	68
Perforation	48	48
Insufficient Information	34	34
Hemorrhage/Bleeding	12	12
Laceration(s)	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
No Code Available	4	4
Cardiac Arrest	4	4
Death	4	4
No Patient Involvement	4	4
Injury	4	4
Laceration(s) of Esophagus	3	3
Perforation of Vessels	3	3
Pneumonia	3	3
Pneumothorax	3	3
Gastroesophageal Burn	3	3
Cardiovascular Insufficiency	2	2
Hyperextension	2	2
Respiratory Failure	2	2
Sepsis	2	2
Bruise/Contusion	2	2
Hemoptysis	2	2
Congenital Defect/Deformity	2	2
High Blood Pressure/ Hypertension	2	2
Necrosis	2	2
Perforation of Esophagus	2	2
Superficial (First Degree) Burn	2	2
Not Applicable	2	2
No Information	2	2
Loss of consciousness	1	1
Pain	1	1
Tingling	1	1
Rupture	1	1
Cardiac Tamponade	1	1
Stenosis	1	1
Hypovolemic Shock	1	1
Hypoxia	1	1
Insufficiency, Valvular	1	1
Erythema	1	1
Hematoma	1	1
Mitral Insufficiency	1	1
Muscle Weakness	1	1
Septic Shock	1	1
Tachycardia	1	1
Thrombosis	1	1
Unspecified Musculoskeletal problem	1	1
Unspecified Tissue Injury	1	1
Unspecified Heart Problem	1	1
Missing Value Reason	1	1
Pancreatitis	1	1
Unspecified Hepatic or Biliary Problem	1	1
Limb Fracture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B-K Medical A/S	II	Jan-25-2024
2	Butterfly Network, Inc.	II	Mar-17-2020
3	Butterfly Network, Inc.	II	Mar-17-2020
4	Canon Medical System, USA, INC.	II	Nov-08-2022
5	ESAOTE S.P.A	II	Sep-30-2020
6	Echonous Inc	II	Jul-10-2024
7	FUJIFILM Healthcare Americas Corporation	II	May-22-2024
8	FujiFilm Healthcare Americas Corporation	II	Nov-02-2021
9	FujiFilm Healthcare Americas Corporation	II	Nov-02-2021
10	GE HEALTHCARE AUSTRIA GMBH & CO	II	Jan-30-2024
11	GE Healthcare, LLC	II	Jul-12-2019
12	GE Healthcare, LLC	II	Jun-18-2019
13	GE Healthcare, LLC	II	Jan-30-2019
14	GE MEDICAL SYSTEMS, ISRAEL LTD.	II	Sep-29-2023
15	GE Medical Systems, LLC	II	Dec-22-2022
16	GE Vingmed Ultrasound As	II	Jul-05-2024
17	GE Vingmed Ultrasound As	II	Jul-10-2023
18	Hitachi Healthcare Americas Corporation	II	Aug-16-2021
19	Hitachi Medical Systems America Inc	II	Mar-19-2021
20	Mindray DS USA, Inc. dba Mindray North America	II	Feb-05-2020
21	NeuroLogica Corporation	II	Aug-14-2019
22	NovaSignal Corp.	II	Jun-27-2024
23	NovaSignal Corp.	II	Feb-01-2023
24	Olympus Corporation of the Americas	II	Nov-27-2020
25	Olympus Corporation of the Americas	II	Mar-12-2019
26	Philips Ultrasound Inc	II	Oct-16-2021
27	Philips Ultrasound Inc	II	Oct-07-2021
28	Philips Ultrasound Inc	II	Aug-16-2021
29	Philips Ultrasound Inc	II	Feb-03-2021
30	Philips Ultrasound Inc	II	Feb-02-2021
31	Philips Ultrasound Inc	II	Jan-14-2021
32	Philips Ultrasound Inc	II	Aug-06-2019
33	Philips Ultrasound, Inc.	II	May-03-2024
34	Philips Ultrasound, Inc.	II	Nov-09-2023
35	Siemens Medical Solutions USA, Inc.	II	Apr-19-2024
36	Siemens Medical Solutions USA, Inc.	II	Sep-13-2023
37	Siemens Medical Solutions USA, Inc.	II	Apr-27-2022
38	Siemens Medical Solutions USA, Inc.	II	Mar-11-2022
39	Siemens Medical Solutions USA, Inc.	II	Feb-03-2022
40	Siemens Medical Solutions USA, Inc.	II	Sep-14-2021
41	Siemens Medical Solutions USA, Inc.	II	Apr-01-2021
42	Siemens Medical Solutions USA, Inc.	II	Aug-22-2019