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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, x-ray, mobile
Product CodeIZL
Regulation Number 892.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
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
ENERGY RESOURCES INTERNATIONAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 29 29

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 17 17
Therapeutic or Diagnostic Output Failure 15 15
Mechanical Problem 13 13
Electrical /Electronic Property Problem 13 13
Smoking 12 12
Computer Operating System Problem 12 12
Improper or Incorrect Procedure or Method 11 11
Break 10 10
No Display/Image 9 9
Device Operational Issue 8 8
Insufficient Information 8 8
Device Fell 8 8
Device Displays Incorrect Message 7 7
Image Display Error/Artifact 6 6
Sparking 6 6
Material Integrity Problem 5 5
Positioning Problem 5 5
Radiation Overexposure 5 5
Battery Problem 5 5
Loose or Intermittent Connection 5 5
Device Handling Problem 5 5
Protective Measures Problem 4 4
Unstable 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Fire 4 4
Thermal Decomposition of Device 3 3
Device Emits Odor 3 3
No Apparent Adverse Event 3 3
Labelling, Instructions for Use or Training Problem 3 3
Degraded 3 3
Unintended Collision 3 3
Computer Software Problem 3 3
Output Problem 3 3
Naturally Worn 3 3
Human-Device Interface Problem 3 3
Product Quality Problem 2 2
Activation Failure 2 2
Arcing 2 2
Electrical Shorting 2 2
Misassembly During Maintenance/Repair 2 2
Material Deformation 2 2
Radiation Output Failure 2 2
Electrical Power Problem 2 2
Unintended Electrical Shock 2 2
Patient Data Problem 2 2
Defective Device 2 2
Data Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 112 113
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
Bruise/Contusion 5 5
Unintended Radiation Exposure 5 5
Death 4 4
Crushing Injury 4 4
Pain 4 4
Patient Problem/Medical Problem 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Code Available 3 3
Hematoma 3 3
Laceration(s) 3 3
Unspecified Infection 2 2
Superficial (First Degree) Burn 2 2
Pneumothorax 2 2
Abrasion 2 2
Unspecified Tissue Injury 2 2
Electric Shock 1 1
Fatigue 1 1
No Information 1 1
Head Injury 1 1
Muscle Weakness 1 1
Chemical Exposure 1 1
Burn(s) 1 1
Nerve Damage 1 1
Hyperextension 1 1
Undesired Nerve Stimulation 1 1
Radiation Burn 1 1
Unspecified Respiratory Problem 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 Aug-22-2024
11 NeuroLogica Corporation II Feb-09-2024
12 NeuroLogica Corporation II Apr-19-2023
13 NeuroLogica Corporation II May-30-2019
14 SEDECAL SA II May-02-2024
15 SEDECAL SA II Feb-14-2024
16 SEDECAL SA II Jun-30-2023
17 SEDECAL SA II Mar-02-2023
18 SEDECAL SA II Nov-04-2022
19 Shimadzu Medical Systems II Dec-04-2020
20 Shimadzu Medical Systems Usa Com II Mar-21-2019
21 Siemens Medical Solutions USA, Inc II Nov-14-2023
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