TPLC - Total Product Life Cycle

• Device: system, x-ray, mobile
• Product Code: IZL
• Regulation Number: 892.1720
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AGFA N.V.
	SUBSTANTIALLY EQUIVALENT	1
ASPENSTATE INC
	SUBSTANTIALLY EQUIVALENT	1
CARESTREAM HEALTH
	SUBSTANTIALLY EQUIVALENT	1
CARESTREAM HEALTH INC.
	SUBSTANTIALLY EQUIVALENT	1
DRGEM CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
FIRST SOURCE INC.
	SUBSTANTIALLY EQUIVALENT	2
GE MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
HDT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
LIVERMORETECH INC.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-X LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MICRO-X LTD.
	SUBSTANTIALLY EQUIVALENT	1
MINXRAY, INC
	SUBSTANTIALLY EQUIVALENT	2
MINXRAY, INC.
	SUBSTANTIALLY EQUIVALENT	1
NANJING PERLOVE MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NANO-X IMAGING LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEUF INC.
	SUBSTANTIALLY EQUIVALENT	2
OXOS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
PHILIPS MEDICAL SYSTEMS DMC GMBH
	SUBSTANTIALLY EQUIVALENT	1
POSKOM CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
RADMEDIX LLC
	SUBSTANTIALLY EQUIVALENT	1
REMEDI CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
SAMSUNG ELECTRONICS CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
SAMSUNG ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SEDECAL SA
	SUBSTANTIALLY EQUIVALENT	5
SEDECAL, SA.
	SUBSTANTIALLY EQUIVALENT	1
SEDECAL., SA.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI)
	SUBSTANTIALLY EQUIVALENT	4
SHENZHEN BROWINER TECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SKANRAY TECHNOLOGIES LIMITED
	SUBSTANTIALLY EQUIVALENT	1
STEPHANIX
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU POWERSITE ELECTRIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VATECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
VMI TECNOLOGIAS LTDA
	SUBSTANTIALLY EQUIVALENT	1
VSI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	40	40
2020	48	48
2021	47	49
2022	32	32
2023	77	77
2024	21	21

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended System Motion	40	42
Unintended Movement	30	30
Use of Device Problem	18	18
Detachment of Device or Device Component	16	16
Therapeutic or Diagnostic Output Failure	15	15
Mechanical Problem	13	13
Electrical /Electronic Property Problem	12	12
Smoking	12	12
Computer Operating System Problem	12	12
Improper or Incorrect Procedure or Method	11	11
No Display/Image	9	9
Break	8	8
Device Operational Issue	8	8
Insufficient Information	8	8
Device Fell	7	7
Device Displays Incorrect Message	7	7
Sparking	6	6
Image Display Error/Artifact	6	6
Battery Problem	5	5
Loose or Intermittent Connection	5	5
Positioning Problem	5	5
Material Integrity Problem	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Protective Measures Problem	4	4
Radiation Overexposure	4	4
Unstable	4	4
Fire	4	4
Device Handling Problem	4	4
Degraded	3	3
Thermal Decomposition of Device	3	3
Computer Software Problem	3	3
Labelling, Instructions for Use or Training Problem	3	3
Device Emits Odor	3	3
Unintended Collision	3	3
Human-Device Interface Problem	3	3
No Apparent Adverse Event	3	3
Naturally Worn	3	3
Output Problem	3	3
Electrical Shorting	2	2
Material Deformation	2	2
Arcing	2	2
Defective Device	2	2
Inadequate or Insufficient Training	2	2
Product Quality Problem	2	2
Activation Failure	2	2
Radiation Output Failure	2	2
Misassembly During Maintenance/Repair	2	2
Data Problem	2	2
Patient Data Problem	2	2
Appropriate Term/Code Not Available	1	1
Unintended Electrical Shock	1	1
Unexpected Shutdown	1	1
No Visual Prompts/Feedback	1	1
Unexpected/Unintended Radiation Output	1	1
Wireless Communication Problem	1	1
Retraction Problem	1	1
Material Separation	1	1
Component Missing	1	1
Failure to Advance	1	1
No Device Output	1	1
Overheating of Device	1	1
Loss of Power	1	1
Use of Incorrect Control/Treatment Settings	1	1
Crack	1	1
Decoupling	1	1
Circuit Failure	1	1
Display or Visual Feedback Problem	1	1
Entrapment of Device	1	1
Melted	1	1
Migration or Expulsion of Device	1	1
Poor Quality Image	1	1
Nonstandard Device	1	1
Device Tipped Over	1	1
Communication or Transmission Problem	1	1
Installation-Related Problem	1	1
Electrical Power Problem	1	1
Connection Problem	1	1
Loss of Data	1	1
Device Markings/Labelling Problem	1	1
Mechanics Altered	1	1
Operating System Version or Upgrade Problem	1	1
Device Difficult to Maintain	1	1
Temperature Problem	1	1
Problem with Software Installation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	104	105
Insufficient Information	48	49
No Known Impact Or Consequence To Patient	27	27
No Consequences Or Impact To Patient	17	17
Bone Fracture(s)	7	7
No Patient Involvement	7	7
Radiation Exposure, Unintended	6	6
Unintended Radiation Exposure	5	5
Bruise/Contusion	5	5
Crushing Injury	4	4
Death	4	4
Pain	4	4
Laceration(s)	3	3
Hematoma	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Code Available	3	3
Patient Problem/Medical Problem	3	3
Abrasion	2	2
Superficial (First Degree) Burn	2	2
Unspecified Tissue Injury	2	2
Unspecified Infection	2	2
Pneumothorax	2	2
Chemical Exposure	1	1
Muscle Weakness	1	1
Nerve Damage	1	1
Undesired Nerve Stimulation	1	1
Head Injury	1	1
Fatigue	1	1
Radiation Burn	1	1
Burn(s)	1	1
Unspecified Respiratory Problem	1	1
Hyperextension	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Agfa N.V.	II	Apr-02-2024
2	Carestream Health, Inc.	II	Dec-01-2023
3	Carestream Health, Inc.	II	Nov-09-2023
4	FUJIFILM Healthcare Americas Corporation	II	Apr-27-2023
5	First Source Inc	II	Jul-01-2024
6	Fujifilm Medical Systems U.S.A., Inc.	II	Aug-30-2019
7	Fujifilm Medical Systems U.S.A., Inc.	II	Mar-21-2019
8	GE Healthcare, LLC	II	Sep-29-2021
9	Micro-X Ltd.	II	Sep-23-2022
10	NeuroLogica Corporation	II	Feb-09-2024
11	NeuroLogica Corporation	II	Apr-19-2023
12	NeuroLogica Corporation	II	May-30-2019
13	SEDECAL SA	II	May-02-2024
14	SEDECAL SA	II	Feb-14-2024
15	SEDECAL SA	II	Jun-30-2023
16	SEDECAL SA	II	Mar-02-2023
17	SEDECAL SA	II	Nov-04-2022
18	Shimadzu Medical Systems	II	Dec-04-2020
19	Shimadzu Medical Systems Usa Com	II	Mar-21-2019
20	Siemens Medical Solutions USA, Inc	II	Nov-14-2023