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	7
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	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	21
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	5
PHILIPS ULTRASOUND, INC.
	SUBSTANTIALLY EQUIVALENT	16
PHYSIOSONICS, INC
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	3
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	38
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	8
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	28
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	2
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	116	116
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	103	103

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended System Motion	293	293
Device Operational Issue	86	86
Adverse Event Without Identified Device or Use Problem	81	81
No Display/Image	67	67
Patient Data Problem	65	65
Data Problem	62	62
Loss of Data	61	61
Application Program Freezes, Becomes Nonfunctional	58	58
Device Operates Differently Than Expected	55	55
Mechanical Jam	45	45
Electrical /Electronic Property Problem	44	44
Poor Quality Image	32	32
Output Problem	31	31
Device Displays Incorrect Message	31	31
Detachment of Device or Device Component	30	30
Unexpected Shutdown	24	24
Fire	22	22
Computer Software Problem	21	21
Use of Device Problem	20	20
Unintended Application Program Shut Down	20	20
Display or Visual Feedback Problem	19	19
Signal Artifact/Noise	18	18
No Device Output	18	18
Incorrect Measurement	17	17
Failure to Power Up	14	14
Smoking	14	14
Insufficient Information	14	14
Operating System Becomes Nonfunctional	14	14
Mechanical Problem	13	13
Break	13	13
Device Emits Odor	12	12
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Loss of Power	12	12
Unstable	12	12
Computer Operating System Problem	12	12
Improper Device Output	11	11
Split	11	11
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
Noise, Audible	8	8
Temperature Problem	7	7
Power Problem	7	7
Improper or Incorrect Procedure or Method	7	7
Visual Prompts will not Clear	6	6
Therapeutic or Diagnostic Output Failure	6	6
Unintended Movement	6	6
Appropriate Term/Code Not Available	6	6
No Visual Prompts/Feedback	6	6
Arcing	6	6
Sharp Edges	5	5
Defective Component	5	5
Erratic or Intermittent Display	5	5
Loose or Intermittent Connection	5	5
Thermal Decomposition of Device	5	5
Circuit Failure	4	4
Display Difficult to Read	4	4
Device Inoperable	4	4
Material Split, Cut or Torn	4	4
Intermittent Loss of Power	4	4
Reset Problem	4	4
Computer System Security Problem	4	4
Communication or Transmission Problem	4	4
Electrical Overstress	4	4
Inadequate User Interface	4	4
Malposition of Device	3	3
Application Program Problem	3	3
Physical Property Issue	3	3
Mechanics Altered	3	3
Unintended Electrical Shock	3	3
Device Stops Intermittently	3	3
Crack	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
Failure to Sense	2	2
Incorrect Software Programming Calculations	2	2
Material Puncture/Hole	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Excessive Heating	2	2
Physical Resistance/Sticking	2	2
Device Fell	2	2
Complete Loss of Power	2	2
Activation Failure	2	2
No Apparent Adverse Event	2	2
Defective Device	2	2
Device Tipped Over	1	1
Charging Problem	1	1
Device Markings/Labelling Problem	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	646	646
No Known Impact Or Consequence To Patient	308	308
No Consequences Or Impact To Patient	251	251
Insufficient Information	60	60
No Information	56	56
Perforation	48	48
No Patient Involvement	15	15
Hemorrhage/Bleeding	14	14
No Code Available	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
Laceration(s) of Esophagus	3	3
Gastroesophageal Burn	3	3
Patient Problem/Medical Problem	3	3
Cardiovascular Insufficiency	2	2
Hyperextension	2	2
Missing Value Reason	2	2
Pregnancy	2	2
Superficial (First Degree) Burn	2	2
Respiratory Failure	2	2
Electric Shock	2	2
Misdiagnosis	2	2
Rupture	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
Cardiac Tamponade	1	1
Stenosis	1	1
Distress	1	1
Tingling	1	1
Cramp(s)	1	1
Dizziness	1	1
Loss of consciousness	1	1
Neck Pain	1	1
Arthralgia	1	1
Sedation	1	1
Heart Failure	1	1
Abdominal Distention	1	1
Burn, Thermal	1	1
Constipation	1	1
Pancreatitis	1	1
Unspecified Hepatic or Biliary Problem	1	1
Limb Fracture	1	1
Unspecified Musculoskeletal problem	1	1
Unspecified Tissue Injury	1	1
Unspecified Heart Problem	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	May-22-2024
15	FujiFilm Healthcare Americas Corporation	II	Nov-02-2021
16	FujiFilm Healthcare Americas Corporation	II	Nov-02-2021
17	GE HEALTHCARE AUSTRIA GMBH & CO	II	Jan-30-2024
18	GE Healthcare, LLC	II	Jul-12-2019
19	GE Healthcare, LLC	II	Jun-18-2019
20	GE Healthcare, LLC	II	Jan-30-2019
21	GE Healthcare, LLC	II	Dec-07-2018
22	GE Healthcare, LLC	II	Apr-11-2017
23	GE Healthcare, LLC	II	Apr-23-2014
24	GE Healthcare, LLC	II	Aug-09-2013
25	GE Healthcare, LLC	II	Aug-01-2013
26	GE Healthcare, LLC	II	Jul-31-2013
27	GE Healthcare, LLC	II	Apr-11-2013
28	GE Healthcare, LLC	II	Feb-23-2012
29	GE Healthcare, LLC	II	Jan-21-2012
30	GE Healthcare, LLC	II	Jan-11-2012
31	GE MEDICAL SYSTEMS, ISRAEL LTD.	II	Sep-29-2023
32	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	II	Sep-06-2018
33	GE Medical Systems, LLC	II	Dec-22-2022
34	GE Vingmed Ultrasound As	II	Jul-10-2023
35	Hitachi Aloka Medical, Ltd.	II	Mar-29-2017
36	Hitachi Healthcare Americas Corporation	II	Aug-16-2021
37	Hitachi Medical Systems America Inc	II	Mar-19-2021
38	Hitachi Medical Systems America Inc	II	May-12-2017
39	Hitachi Medical Systems America Inc	II	Jun-08-2011
40	Konica Minolta Medical Imaging USA, Inc.	II	Mar-27-2018
41	Konica Minolta, Inc.	II	Jul-26-2017
42	Mindray DS USA, Inc. dba Mindray North America	II	Feb-05-2020
43	NeuroLogica Corporation	II	Aug-14-2019
44	NovaSignal Corp.	II	Feb-01-2023
45	Olympus Corporation of the Americas	II	Nov-27-2020
46	Olympus Corporation of the Americas	II	Mar-12-2019
47	Philips Medical Systems Nederlands	II	Apr-25-2011
48	Philips Medical Systems North America Inc.	II	Mar-20-2014
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