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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
FIRST SOURCE INC.
  SUBSTANTIALLY EQUIVALENT 1
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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 40 42
Unintended Movement 29 29
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
Computer Operating System Problem 12 12
Electrical /Electronic Property Problem 11 11
Improper or Incorrect Procedure or Method 11 11
Smoking 11 11
No Display/Image 9 9
Break 8 8
Device Operational Issue 8 8
Device Displays Incorrect Message 7 7
Insufficient Information 7 7
Sparking 6 6
Image Display Error/Artifact 6 6
Device Fell 6 6
Loose or Intermittent Connection 5 5
Battery Problem 5 5
Material Integrity Problem 5 5
Positioning Problem 5 5
Protective Measures Problem 4 4
Radiation Overexposure 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Device Handling Problem 4 4
Unstable 4 4
Fire 4 4
Degraded 3 3
Labelling, Instructions for Use or Training Problem 3 3
Thermal Decomposition of Device 3 3
Computer Software Problem 3 3
Device Emits Odor 3 3
Unintended Collision 3 3
Naturally Worn 3 3
Output Problem 3 3
Human-Device Interface Problem 3 3
No Apparent Adverse Event 3 3
Misassembly During Maintenance/Repair 2 2
Radiation Output Failure 2 2
Electrical Shorting 2 2
Material Deformation 2 2
Arcing 2 2
Defective Device 2 2
Activation Failure 2 2
Data Problem 2 2
Patient Data Problem 2 2
Product Quality Problem 2 2
Inadequate or Insufficient Training 2 2
Component Missing 1 1
Failure to Advance 1 1
Retraction Problem 1 1
Material Separation 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
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
Wireless Communication Problem 1 1
Device Difficult to Maintain 1 1
Mechanics Altered 1 1
Temperature Problem 1 1
Problem with Software Installation 1 1
Device Tipped Over 1 1
Connection Problem 1 1
Loss of Data 1 1
Communication or Transmission Problem 1 1
Installation-Related Problem 1 1
Electrical Power Problem 1 1
Device Markings/Labelling Problem 1 1
Unexpected/Unintended Radiation Output 1 1
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
No Visual Prompts/Feedback 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 97 98
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
Unspecified Respiratory Problem 1 1
Hyperextension 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AGFA US CORP 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 Fujifilm Medical Systems U.S.A., Inc. II Aug-30-2019
6 Fujifilm Medical Systems U.S.A., Inc. II Mar-21-2019
7 GE Healthcare, LLC II Sep-29-2021
8 Micro-X Ltd. II Sep-23-2022
9 NeuroLogica Corporation II Feb-09-2024
10 NeuroLogica Corporation II Apr-19-2023
11 NeuroLogica Corporation II May-30-2019
12 SEDECAL SA II May-02-2024
13 SEDECAL SA II Feb-14-2024
14 SEDECAL SA II Jun-30-2023
15 SEDECAL SA II Mar-02-2023
16 SEDECAL SA II Nov-04-2022
17 Shimadzu Medical Systems II Dec-04-2020
18 Shimadzu Medical Systems Usa Com II Mar-21-2019
19 Siemens Medical Solutions USA, Inc II Nov-14-2023
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