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
ACCUTOME, INC.
	SUBSTANTIALLY EQUIVALENT	1
ACO HEALTHCARE CO,. LTD.
	SUBSTANTIALLY EQUIVALENT	1
ACO HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED INSTRUMENTATIONS, INC
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED INSTRUMENTATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALOKA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ALPINION MEDICAL SYSTEMS CO., LTD
	SUBSTANTIALLY EQUIVALENT	10
ALPINION MEDICAL SYSTEMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	15
ATYS
	SUBSTANTIALLY EQUIVALENT	1
B-K MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	5
BARD ACCESS SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BEIJING KONTED MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BENQ MEDICAL TECHNOLOGY CORPATION
	SUBSTANTIALLY EQUIVALENT	1
BIONET CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BK MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	9
BRONCUS TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BUTTERFLY NETWORK, INC.
	SUBSTANTIALLY EQUIVALENT	3
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CANON MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	13
CARESTREAM HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
CHANG GUNG MEDICAL SUPPLIES & EQUIPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	1
CHANG GUNG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC
	SUBSTANTIALLY EQUIVALENT	1
CHISON MEDICAL IMAGING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	10
CHISON MEDICAL TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	8
CLARIUS MOBILE HEALTH CORP.
	SUBSTANTIALLY EQUIVALENT	6
COMPAL ELECTRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CRYSTALLINE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
E-SCOPICS
	SUBSTANTIALLY EQUIVALENT	2
ECHONOUS, INC.
	SUBSTANTIALLY EQUIVALENT	2
EDAN INSTRUMENTS INC
	SUBSTANTIALLY EQUIVALENT	3
EDAN INSTRUMENTS, INC
	SUBSTANTIALLY EQUIVALENT	3
EDAN INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	5
ESAOTE EUROPE B.V.
	SUBSTANTIALLY EQUIVALENT	4
ESAOTE S.P.A
	SUBSTANTIALLY EQUIVALENT	3
ESAOTE S.P.A.
	SUBSTANTIALLY EQUIVALENT	10
ESAOTE, S.P.A.
	SUBSTANTIALLY EQUIVALENT	9
ESCALON MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
EXACT IMAGING INC.
	SUBSTANTIALLY EQUIVALENT	1
EXACT IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXO IMAGING INC.
	SUBSTANTIALLY EQUIVALENT	2
EZONO AG
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM SONOSITE INC.
	SUBSTANTIALLY EQUIVALENT	2
FUJIFILM SONOSITE, INC.
	SUBSTANTIALLY EQUIVALENT	12
FUJIFILM SONOSITE,INC.
	SUBSTANTIALLY EQUIVALENT	7
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	52
GE MEDICAL SYSTEM ISRAEL LTD.
	SUBSTANTIALLY EQUIVALENT	2
GE MEDICAL SYSTEM ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	3
GE MEDICAL SYSTEMS CHINA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
GE MEDICAL SYSTEMS ISRAEL LTD.
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTIC, LLC
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
	SUBSTANTIALLY EQUIVALENT	7
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	17
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
	SUBSTANTIALLY EQUIVALENT	22
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOTICS, L
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSYEMS ULTRASOUND & PRIMARY CARE DIAGN
	SUBSTANTIALLY EQUIVALENT	1
GE VINGMED ULTRASOUND AS
	SUBSTANTIALLY EQUIVALENT	2
GUANGDONG YOUKEY MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HEALCERION CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
HEALCERION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HITACHI ALOKA MEDICAL AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
HITACHI ALOKA MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	5
HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
HITACHI HEALTHCARE AMERICAS
	SUBSTANTIALLY EQUIVALENT	4
HITACHI HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
HITACHI MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
HITACHI MEDICAL SYSTEMS AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	2
HITACHI, LTD
	SUBSTANTIALLY EQUIVALENT	1
HITACHI, LTD.
	SUBSTANTIALLY EQUIVALENT	2
IMACOR INC
	SUBSTANTIALLY EQUIVALENT	1
IMACOR INC.
	SUBSTANTIALLY EQUIVALENT	1
IMSONIC MEDICAL CHINA, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTERSON CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
KOELIS
	SUBSTANTIALLY EQUIVALENT	2
KOLO MEDICAL (SUZHOU) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
KONICA MINOLTA INC.
	SUBSTANTIALLY EQUIVALENT	1
KONICA MINOLTA, INC.
	SUBSTANTIALLY EQUIVALENT	3
LELTEK INC
	SUBSTANTIALLY EQUIVALENT	3
LIFE-TECH, INC.
	SUBSTANTIALLY EQUIVALENT	2
LINKQUEST INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDISON CO., LTD.
	SUBSTANTIALLY EQUIVALENT	6
MEDISONO
	SUBSTANTIALLY EQUIVALENT	1
MEDISONO, LLC
	SUBSTANTIALLY EQUIVALENT	2
METRITRACK LLC
	SUBSTANTIALLY EQUIVALENT	1
NATIONAL TAIWAN UNIVERSITY
	SUBSTANTIALLY EQUIVALENT	1
NAVIGANT CONSULTING - ON BEHALF OF ESAOTE S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
NEURAL ANALYTICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
NEUROCHAOS SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NOVASIGNAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NU VUE THERAPEUTICS, INC
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	3
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PANASONIC HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
PENRITH CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	7
PHILIPS HEALTHCARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS ULTRASOUND
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS ULTRASOUND LLC
	SUBSTANTIALLY EQUIVALENT	4
PHILIPS ULTRASOUND, INC.
	SUBSTANTIALLY EQUIVALENT	16
PHYSIOSONICS, INC
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
QISDA CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
RIMED LTD.
	SUBSTANTIALLY EQUIVALENT	1
SAMSUNG MEDISON CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SAMSUNG MEDISON CO., LTD
	SUBSTANTIALLY EQUIVALENT	20
SAMSUNG MEDISON CO., LTD.
	SUBSTANTIALLY EQUIVALENT	37
SASET (CHENGDU) INC.
	SUBSTANTIALLY EQUIVALENT	1
SENO MEDICAL INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI
	SUBSTANTIALLY EQUIVALENT	3
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD (SIUI)
	SUBSTANTIALLY EQUIVALENT	1
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI)
	SUBSTANTIALLY EQUIVALENT	3
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SHENZHEN DELICATE ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	47
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	7
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	4
SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
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 SOLUTION
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS INC. ULTRASOUND GROUP
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS USA INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS USA, INC
	SUBSTANTIALLY EQUIVALENT	9
SIEMENS MEDICAL SOLUTIONS USA, INC.
	SUBSTANTIALLY EQUIVALENT	27
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GROUP
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS MEDICAL SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	6
SIEMENS MEDICAL SOLUTIONS, INC., ULTRASOUND DIVISION
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS, USA, INC
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS, USA, INC.
	SUBSTANTIALLY EQUIVALENT	3
SIEMENS MEDICAL SOLUTIONS, USA, INC. ULTRASOUND GROUP
	SUBSTANTIALLY EQUIVALENT	1
SIGNOSTICS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SIGNOSTICS PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
SILICON VALLY MEDICAL INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SONIO
	SUBSTANTIALLY EQUIVALENT	1
SONOSCANNER
	SUBSTANTIALLY EQUIVALENT	2
SONOSCANNER SARL
	SUBSTANTIALLY EQUIVALENT	2
SONOSCAPE COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	16
SONOSCAPE MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	18
SONOSITE,INC.
	SUBSTANTIALLY EQUIVALENT	2
SUPERSONIC IMAGINE
	SUBSTANTIALLY EQUIVALENT	14
SYNOVIS MICRO COMPANIES ALLIANCE
	SUBSTANTIALLY EQUIVALENT	1
TELEMED
	SUBSTANTIALLY EQUIVALENT	3
TERATECH CORP.
	SUBSTANTIALLY EQUIVALENT	8
TERATECH CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
TISSUE DIFFERENTIATION INTELLIGENCE, LLC
	SUBSTANTIALLY EQUIVALENT	1
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	6
TOSHIBA MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	16
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
	SUBSTANTIALLY EQUIVALENT	1
TOYOTA TSUSHO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ULTRASONIX MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
UNITED IMAGING SYSTEMS (BEIJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VENTRIPOINT DIAGNOSTICS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
VENTRIPOINT, INC.
	SUBSTANTIALLY EQUIVALENT	2
VIASONIX LTD.
	SUBSTANTIALLY EQUIVALENT	3
VINNO TECHNOLOGY (SUZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
VINNO TECHNOLOGY (SUZHOU) CO.,LTD
	SUBSTANTIALLY EQUIVALENT	2
VINNO TECHNOLOGY (SUZHOU) CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
WINPROBE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WIPRO GE HEALTHCARE PRIVATE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN ZONCARE BIO-MEDICAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZONARE MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	5

MDR Year	MDR Reports	MDR Events
2014	48	48
2015	115	115
2016	145	145
2017	146	146
2018	84	84
2019	59	59
2020	67	67
2021	213	213
2022	186	186
2023	229	229
2024	63	63

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended System Motion	278	278
Device Operational Issue	86	86
Adverse Event Without Identified Device or Use Problem	80	80
No Display/Image	67	67
Patient Data Problem	64	64
Data Problem	60	60
Loss of Data	57	57
Device Operates Differently Than Expected	55	55
Application Program Freezes, Becomes Nonfunctional	54	54
Mechanical Jam	43	43
Electrical /Electronic Property Problem	36	36
Output Problem	31	31
Device Displays Incorrect Message	31	31
Detachment of Device or Device Component	30	30
Poor Quality Image	30	30
Unexpected Shutdown	23	23
Fire	22	22
Computer Software Problem	20	20
Display or Visual Feedback Problem	19	19
Use of Device Problem	19	19
Unintended Application Program Shut Down	19	19
No Device Output	18	18
Signal Artifact/Noise	18	18
Incorrect Measurement	15	15
Smoking	14	14
Insufficient Information	14	14
Operating System Becomes Nonfunctional	14	14
Failure to Power Up	13	13
Mechanical Problem	13	13
Break	13	13
Loss of Power	12	12
Unstable	12	12
Computer Operating System Problem	12	12
Improper Device Output	11	11
Device Emits Odor	11	11
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Overheating of Device	9	9
Image Display Error/Artifact	9	9
Battery Problem	9	9
Sparking	8	8
Flare or Flash	8	8
Device Dislodged or Dislocated	8	8
Split	8	8
Temperature Problem	7	7
Power Problem	7	7
Noise, Audible	7	7
No Visual Prompts/Feedback	6	6
Therapeutic or Diagnostic Output Failure	6	6
Unintended Movement	6	6
Appropriate Term/Code Not Available	6	6
Arcing	6	6
Improper or Incorrect Procedure or Method	6	6
Visual Prompts will not Clear	6	6
Defective Component	5	5
Erratic or Intermittent Display	5	5
Loose or Intermittent Connection	5	5
Thermal Decomposition of Device	4	4
Display Difficult to Read	4	4
Device Inoperable	4	4
Computer System Security Problem	4	4
Communication or Transmission Problem	4	4
Electrical Overstress	4	4
Inadequate User Interface	4	4
Reset Problem	4	4
Intermittent Loss of Power	4	4
Material Split, Cut or Torn	4	4
Sharp Edges	4	4
Physical Property Issue	3	3
Mechanics Altered	3	3
Malposition of Device	3	3
Application Program Problem	3	3
Device Stops Intermittently	3	3
Crack	3	3
Circuit Failure	3	3
Application Interface Becomes Non-Functional Or Program Exits Abnormally	2	2
Melted	2	2
Image Orientation Incorrect	2	2
Failure to Align	2	2
Failure to Advance	2	2
Component Missing	2	2
Device Issue	2	2
Failure to Calibrate	2	2
Application Program Problem: Parameter Calculation Error	2	2
Failure to Run on Battery	2	2
Incorrect Software Programming Calculations	2	2
Material Puncture/Hole	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Defective Device	2	2
Activation Failure	2	2
No Apparent Adverse Event	2	2
Device Fell	2	2
Complete Loss of Power	2	2
Physical Resistance/Sticking	2	2
Unintended Electrical Shock	2	2
Excessive Heating	1	1
Program or Algorithm Execution Problem	1	1
Delayed Program or Algorithm Execution	1	1
Activation Problem	1	1
Failure to Clean Adequately	1	1
Unclear Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	605	605
No Known Impact Or Consequence To Patient	306	306
No Consequences Or Impact To Patient	250	250
No Information	56	56
Insufficient Information	48	48
Perforation	47	47
No Patient Involvement	15	15
No Code Available	13	13
Hemorrhage/Bleeding	13	13
Death	9	9
Injury	8	8
Not Applicable	6	6
Perforation of Esophagus	5	5
Burn(s)	5	5
Laceration(s)	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Cardiac Arrest	4	4
Pneumothorax	4	4
Pneumonia	3	3
Hematoma	3	3
Bruise/Contusion	3	3
Perforation of Vessels	3	3
Pain	3	3
Patient Problem/Medical Problem	3	3
Hyperextension	2	2
Laceration(s) of Esophagus	2	2
Respiratory Failure	2	2
Rupture	2	2
Misdiagnosis	2	2
Cardiovascular Insufficiency	2	2
Gastroesophageal Burn	2	2
Missing Value Reason	2	2
Pregnancy	2	2
Superficial (First Degree) Burn	2	2
Electric Shock	2	2
Sepsis	2	2
Shock	2	2
Necrosis	2	2
Hemoptysis	2	2
Congenital Defect/Deformity	2	2
Breast Cancer	2	2
High Blood Pressure/ Hypertension	2	2
Hypovolemic Shock	1	1
Hypoxia	1	1
Insufficiency, Valvular	1	1
Miscarriage	1	1
Mitral Insufficiency	1	1
Muscle Weakness	1	1
Erythema	1	1
Flatus	1	1
Headache	1	1
Respiratory Distress	1	1
Seizures	1	1
Swelling	1	1
Tachycardia	1	1
Thrombosis	1	1
Thrombus	1	1
Septic Shock	1	1
Burning Sensation	1	1
Abdominal Distention	1	1
Constipation	1	1
Pancreatitis	1	1
Unspecified Hepatic or Biliary Problem	1	1
Limb Fracture	1	1
Unspecified Heart Problem	1	1
Tingling	1	1
Cramp(s)	1	1
Dizziness	1	1
Cardiac Tamponade	1	1
Distress	1	1
Heart Failure	1	1
Burn, Thermal	1	1
Loss of consciousness	1	1
Neck Pain	1	1
Arthralgia	1	1
Sedation	1	1
Unspecified Musculoskeletal problem	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B-K Medical A/S	II	Jan-25-2024
2	B-K Medical A/S	II	Aug-03-2016
3	Bard Access Systems	II	Jul-11-2011
4	Boston Scientific Corporation	II	Apr-22-2014
5	Butterfly Network, Inc.	II	Mar-17-2020
6	Butterfly Network, Inc.	II	Mar-17-2020
7	Canon Medical System, USA, INC.	II	Nov-08-2022
8	Cardinal Health, Inc	II	Apr-07-2009
9	Carestream Health Inc	II	Jan-19-2017
10	Carestream Health Inc	II	Jul-18-2016
11	ESAOTE S.P.A	II	Sep-30-2020
12	ESAOTE S.P.A.	II	Oct-23-2018
13	ESAOTE S.P.A.	II	Mar-20-2018
14	FujiFilm Healthcare Americas Corporation	II	Nov-02-2021
15	FujiFilm Healthcare Americas Corporation	II	Nov-02-2021
16	GE HEALTHCARE AUSTRIA GMBH & CO	II	Jan-30-2024
17	GE Healthcare, LLC	II	Jul-12-2019
18	GE Healthcare, LLC	II	Jun-18-2019
19	GE Healthcare, LLC	II	Jan-30-2019
20	GE Healthcare, LLC	II	Dec-07-2018
21	GE Healthcare, LLC	II	Apr-11-2017
22	GE Healthcare, LLC	II	Apr-23-2014
23	GE Healthcare, LLC	II	Aug-09-2013
24	GE Healthcare, LLC	II	Aug-01-2013
25	GE Healthcare, LLC	II	Jul-31-2013
26	GE Healthcare, LLC	II	Apr-11-2013
27	GE Healthcare, LLC	II	Feb-23-2012
28	GE Healthcare, LLC	II	Jan-21-2012
29	GE Healthcare, LLC	II	Jan-11-2012
30	GE MEDICAL SYSTEMS, ISRAEL LTD.	II	Sep-29-2023
31	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	II	Sep-06-2018
32	GE Medical Systems, LLC	II	Dec-22-2022
33	GE Vingmed Ultrasound As	II	Jul-10-2023
34	Hitachi Aloka Medical, Ltd.	II	Mar-29-2017
35	Hitachi Healthcare Americas Corporation	II	Aug-16-2021
36	Hitachi Medical Systems America Inc	II	Mar-19-2021
37	Hitachi Medical Systems America Inc	II	May-12-2017
38	Hitachi Medical Systems America Inc	II	Jun-08-2011
39	Konica Minolta Medical Imaging USA, Inc.	II	Mar-27-2018
40	Konica Minolta, Inc.	II	Jul-26-2017
41	Mindray DS USA, Inc. dba Mindray North America	II	Feb-05-2020
42	NeuroLogica Corporation	II	Aug-14-2019
43	NovaSignal Corp.	II	Feb-01-2023
44	Olympus Corporation of the Americas	II	Nov-27-2020
45	Olympus Corporation of the Americas	II	Mar-12-2019
46	Philips Medical Systems Nederlands	II	Apr-25-2011
47	Philips Medical Systems North America Inc.	II	Mar-20-2014
48	Philips Medical Systems North America Inc.	II	Nov-20-2013
49	Philips Ultrasound Inc	II	Oct-16-2021
50	Philips Ultrasound Inc	II	Oct-07-2021
51	Philips Ultrasound Inc	II	Aug-16-2021
52	Philips Ultrasound Inc	II	Feb-03-2021
53	Philips Ultrasound Inc	II	Feb-02-2021
54	Philips Ultrasound Inc	II	Jan-14-2021
55	Philips Ultrasound Inc	II	Aug-06-2019
56	Philips Ultrasound, Inc.	II	Nov-09-2023
57	Philips Ultrasound, Inc.	II	Apr-13-2016
58	Philips Ultrasound, Inc.	II	Jan-06-2016
59	Philips Ultrasound, Inc.	II	May-19-2015
60	Philips Ultrasound, Inc.	II	May-05-2015
61	Philips Ultrasound, Inc.	II	Dec-16-2014
62	Siemens Medical Solutions USA, Inc.	II	Apr-19-2024
63	Siemens Medical Solutions USA, Inc.	II	Sep-13-2023
64	Siemens Medical Solutions USA, Inc.	II	Apr-27-2022
65	Siemens Medical Solutions USA, Inc.	II	Mar-11-2022
66	Siemens Medical Solutions USA, Inc.	II	Feb-03-2022
67	Siemens Medical Solutions USA, Inc.	II	Sep-14-2021
68	Siemens Medical Solutions USA, Inc.	II	Apr-01-2021
69	Siemens Medical Solutions USA, Inc.	II	Aug-22-2019
70	Siemens Medical Solutions USA, Inc.	II	Mar-26-2018
71	Siemens Medical Solutions USA, Inc.	II	Mar-15-2018
72	Siemens Medical Solutions USA, Inc.	II	Apr-24-2017
73	Siemens Medical Solutions USA, Inc.	II	Nov-28-2016
74	Siemens Medical Solutions USA, Inc.	II	May-02-2016
75	Siemens Medical Solutions USA, Inc.	II	Apr-27-2016
76	Siemens Medical Solutions USA, Inc.	II	Oct-30-2015
77	Siemens Medical Solutions USA, Inc.	II	Sep-17-2015
78	Siemens Medical Solutions USA, Inc.	II	Aug-05-2015
79	Siemens Medical Solutions USA, Inc.	II	Jul-30-2015
80	Siemens Medical Solutions USA, Inc.	II	Jul-29-2015
81	Siemens Medical Solutions USA, Inc.	II	Jul-02-2015
82	Siemens Medical Solutions USA, Inc.	II	May-06-2015
83	Siemens Medical Solutions USA, Inc.	II	Feb-05-2015
84	Siemens Medical Solutions USA, Inc.	II	Jul-01-2014
85	Siemens Medical Solutions USA, Inc.	II	May-28-2014
86	Siemens Medical Solutions USA, Inc.	II	May-28-2014
87	Siemens Medical Solutions USA, Inc.	II	Apr-24-2014
88	Siemens Medical Solutions USA, Inc.	II	Apr-03-2014
89	Siemens Medical Solutions USA, Inc.	II	Jan-24-2014
90	Siemens Medical Solutions USA, Inc.	II	Jan-24-2014
91	Siemens Medical Solutions USA, Inc.	II	Oct-23-2013
92	Siemens Medical Solutions USA, Inc.	II	Apr-10-2013
93	Siemens Medical Solutions USA, Inc.	II	May-16-2012
94	Siemens Medical Solutions USA, Inc.	II	May-06-2011
95	Siemens Medical Solutions USA, Inc.	II	Apr-29-2011
96	Siemens Medical Solutions USA, Inc.	II	Apr-25-2011
97	Siemens Medical Solutions USA, Inc.	II	Apr-22-2011
98	Siemens Medical Solutions USA, Inc.	II	Apr-08-2011
99	Siemens Medical Solutions USA, Inc.	II	Mar-30-2011
100	Siemens Medical Solutions USA, Inc.	II	Mar-28-2011