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
CIVCO MEDICAL INSTRUMENTS CO., INC.
	SUBSTANTIALLY EQUIVALENT	3
CIVCO MEDICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
EXACT MEDICAL MANUFACTURING
	SUBSTANTIALLY EQUIVALENT	2
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL PROTECTION CORP.
	SUBSTANTIALLY EQUIVALENT	1
HONY MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HUNTLEIGH HEALTHCARE LIMITED
	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	1074	1074
Break	172	172
Material Deformation	91	91
Leak/Splash	88	88
Material Twisted/Bent	78	79
Adverse Event Without Identified Device or Use Problem	58	60
Detachment of Device or Device Component	53	54
No Display/Image	52	52
Fluid/Blood Leak	49	49
Deformation Due to Compressive Stress	43	43
Material Split, Cut or Torn	39	40
No Apparent Adverse Event	38	38
Failure to Clean Adequately	31	31
Stretched	29	29
Material Integrity Problem	26	27
Defective Component	26	26
Entrapment of Device	25	25
Material Puncture/Hole	25	25
Device Contamination with Body Fluid	23	23
Data Problem	21	21
Contamination /Decontamination Problem	20	22
Scratched Material	16	16
Material Separation	15	15
Product Quality Problem	15	17
Device Reprocessing Problem	14	14
Unexpected Shutdown	13	13
Contamination	13	13
Application Program Freezes, Becomes Nonfunctional	12	12
Mechanical Problem	12	12
Defective Device	12	12
Output Problem	11	11
Improper or Incorrect Procedure or Method	10	10
Crack	10	10
Mechanical Jam	10	10
Gas/Air Leak	9	9
Device Contamination with Chemical or Other Material	9	9
Display or Visual Feedback Problem	8	8
Insufficient Information	8	8
Dent in Material	8	8
Nonstandard Device	7	9
Degraded	7	7
Patient-Device Incompatibility	6	6
Failure to Advance	6	6
Patient Device Interaction Problem	6	6
Failure to Conduct	5	5
Image Display Error/Artifact	5	5
Therapeutic or Diagnostic Output Failure	5	5
Microbial Contamination of Device	5	5
Overheating of Device	4	4
Material Perforation	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1962	1964
Insufficient Information	31	35
No Consequences Or Impact To Patient	24	24
Foreign Body In Patient	18	18
Hemorrhage/Bleeding	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Pneumothorax	14	14
Bacterial Infection	11	15
Vascular Dissection	6	6
Perforation of Vessels	5	5
Pain	5	5
Unspecified Infection	4	4
Pneumonia	4	4
Fever	4	4
Ectopic Pregnancy	3	3
Pancreatitis	3	3
Sepsis	3	3
Perforation of Esophagus	3	3
Itching Sensation	3	3
Rash	3	3
Skin Burning Sensation	2	2
Urinary Tract Infection	2	2
Respiratory Failure	2	2
Fibrosis	2	2
Hypoxia	2	2
Fluid Discharge	2	2
Laceration(s)	2	2
No Patient Involvement	2	2
Urinary Retention	2	2
Thrombosis/Thrombus	2	2
Burning Sensation	2	2
No Known Impact Or Consequence To Patient	2	2
Vaginal Mucosa Damage	2	2
Cardiac Arrest	2	2
Obstruction/Occlusion	2	2
Laceration(s) of Esophagus	2	2
Air Embolism	2	2
Electric Shock	2	2
Hemoptysis	2	2
Gastroesophageal Burn	2	2
Decreased Appetite	1	1
Device Embedded In Tissue or Plaque	1	1
Fistula	1	1
Embolus	1	1
Superficial (First Degree) Burn	1	1
Low Oxygen Saturation	1	1
Premature Labor	1	1
Abortion	1	1
Syncope/Fainting	1	1
Sore Throat	1	1

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	May-30-2025
8	DJO, LLC	I	Oct-05-2021
9	ESAOTE S.P.A.	II	Mar-03-2026
10	Exact Medical Manufacturing, Inc.	II	Jun-21-2021
11	GE Medical Systems, LLC	II	Dec-22-2022
12	Huntleigh Healthcare Ltd.	II	Apr-20-2022
13	ImaCor Inc.	II	Oct-03-2025
14	ImaCor Inc.	II	Oct-25-2024
15	Lumenis, Inc.	I	Nov-04-2021
16	Mac Medical Supply Co Inc	I	Sep-17-2021
17	National Distribution & Contracting Inc	I	Oct-13-2021
18	North Coast Medical Inc	I	Sep-29-2021
19	Olympus Corporation of the Americas	II	May-05-2022
20	Philips Ultrasound, Inc	III	Mar-24-2026
21	Philips Ultrasound, Inc	III	Aug-22-2025
22	Philips Ultrasound, Inc	II	Jul-02-2025
23	Philips Ultrasound, Inc.	II	Sep-06-2023
24	Red Medical Supplies	I	Oct-14-2021
25	Scrip Inc	I	Nov-17-2021
26	Sheathing Technologies Inc	II	Dec-31-2025