TPLC - Total Product Life Cycle

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Device	transducer, ultrasonic, diagnostic
Regulation Description	Diagnostic ultrasonic transducer.
Product Code	ITX
Regulation Number	892.1570
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADVANCE MEDICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CIVCO MEDICAL INSTRUMENTS CO., INC.
	SUBSTANTIALLY EQUIVALENT	3
CIVCO MEDICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	2
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
EXACT MEDICAL MANUFACTURING
	SUBSTANTIALLY EQUIVALENT	2
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL PROTECTION CORP.
	SUBSTANTIALLY EQUIVALENT	1
HONY MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HUNTLEIGH HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
KOELIS
	SUBSTANTIALLY EQUIVALENT	1
MEDXPRESS.PRO
	SUBSTANTIALLY EQUIVALENT	1
MENDAERA, INC.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
PARKER LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
RIVANNA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
VITROLIFE SWEDEN AB
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Poor Quality Image	1078	1078
Break	143	143
Adverse Event Without Identified Device or Use Problem	101	103
Leak/Splash	79	79
Material Deformation	63	63
Material Twisted/Bent	62	62
No Display/Image	51	51
Fluid/Blood Leak	49	49
Detachment of Device or Device Component	47	47
Defective Component	39	39
Deformation Due to Compressive Stress	38	38
Entrapment of Device	31	31
Material Split, Cut or Torn	30	31
Failure to Clean Adequately	30	30
Stretched	27	27
Material Puncture/Hole	23	23
Device Contamination with Body Fluid	22	22
Material Integrity Problem	22	22
Mechanical Problem	20	20
Contamination /Decontamination Problem	19	21
Defective Device	19	19
No Apparent Adverse Event	18	18
Image Display Error/Artifact	17	17
Data Problem	16	16
Mechanical Jam	16	16
Material Separation	16	16
Positioning Problem	14	14
Display or Visual Feedback Problem	14	14
Therapeutic or Diagnostic Output Failure	13	13
Contamination	12	12
Output Problem	12	12
Device Reprocessing Problem	12	12
Scratched Material	11	11
Improper or Incorrect Procedure or Method	11	11
Device Contamination with Chemical or Other Material	10	10
Failure to Advance	10	10
Crack	10	10
Device Operates Differently Than Expected	9	9
Application Program Freezes, Becomes Nonfunctional	9	9
Signal Artifact/Noise	8	8
Nonstandard Device	7	9
Loss of Power	7	7
Patient-Device Incompatibility	6	6
Physical Resistance/Sticking	6	6
Device Displays Incorrect Message	6	6
Battery Problem	6	6
Temperature Problem	6	6
Microbial Contamination of Device	6	6
Unexpected Shutdown	6	6
Degraded	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1702	1703
No Known Impact Or Consequence To Patient	148	148
No Consequences Or Impact To Patient	147	147
Insufficient Information	32	36
Pneumothorax	22	22
No Patient Involvement	20	20
Foreign Body In Patient	19	19
Hemorrhage/Bleeding	18	18
Perforation of Esophagus	12	12
No Code Available	11	11
Bacterial Infection	11	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Stenosis	9	9
Unspecified Infection	7	7
Injury	6	6
Vascular Dissection	6	6
Perforation of Vessels	5	5
Burn, Thermal	5	5
Laceration(s) of Esophagus	5	5
Patient Problem/Medical Problem	4	4
Pneumonia	4	4
Pain	4	4
Chest Pain	4	4
Rash	4	4
Fever	4	4
No Information	4	4
Laceration(s)	3	3
Itching Sensation	3	3
Perforation	3	3
Pancreatitis	3	3
Sepsis	3	3
Air Embolism	2	2
Fluid Discharge	2	2
Ectopic Pregnancy	2	2
Electric Shock	2	2
Dyspnea	2	2
Hypoxia	2	2
Urinary Retention	2	2
Skin Burning Sensation	2	2
Thrombosis/Thrombus	2	2
Device Embedded In Tissue or Plaque	2	2
Needle Stick/Puncture	2	2
Burning Sensation	2	2
Gastroesophageal Burn	2	2
Urinary Tract Infection	2	2
Vaginal Mucosa Damage	2	2
Cardiac Arrest	2	2
Necrosis	2	2
Obstruction/Occlusion	2	2
Respiratory Failure	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	AMTEC SALES Inc	I	Sep-22-2021
2	Accelerated Care Plus Corporation	I	Sep-25-2021
3	Advance Medical Designs, Inc.	II	Sep-09-2023
4	Aesthetics Systems Usa Inc	I	Oct-06-2021
5	Aizu Olympus Co., Ltd.	II	Nov-17-2023
6	Athena Medical Products Inc	I	Sep-09-2021
7	CIVCO Medical Instruments Co., Inc.	II	Dec-07-2018
8	Civco Medical Instruments Co. Inc.	II	May-30-2025
9	Civco Medical Instruments Co. Inc.	II	Aug-29-2018
10	Civco Medical Instruments Co. Inc.	II	Aug-22-2018
11	DJO, LLC	I	Oct-05-2021
12	Exact Medical Manufacturing, Inc.	II	Jun-21-2021
13	GE Medical Systems, LLC	II	Dec-22-2022
14	Hitachi Medical Systems America Inc	II	Feb-20-2020
15	Hitachi Medical Systems America Inc	II	Mar-01-2018
16	Huntleigh Healthcare Ltd.	II	Apr-20-2022
17	ImaCor Inc.	II	Oct-03-2025
18	ImaCor Inc.	II	Oct-25-2024
19	Lumenis, Inc.	I	Nov-04-2021
20	Mac Medical Supply Co Inc	I	Sep-17-2021
21	National Distribution & Contracting Inc	I	Oct-13-2021
22	North Coast Medical Inc	I	Sep-29-2021
23	Olympus Corporation of the Americas	II	May-05-2022
24	Olympus Corporation of the Americas	II	Nov-27-2020
25	Philips Ultrasound Inc	II	May-01-2020
26	Philips Ultrasound, Inc	III	Aug-22-2025
27	Philips Ultrasound, Inc	II	Jul-02-2025
28	Philips Ultrasound, Inc.	II	Sep-06-2023
29	Red Medical Supplies	I	Oct-14-2021
30	Scrip Inc	I	Nov-17-2021
31	Verathon, Inc.	II	Dec-03-2020