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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device system, x-ray, mobile
Regulation Description Mobile x-ray system.
Product CodeIZL
Regulation Number 892.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
AGFA N.V.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
HUESTIS MACHINE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-X LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MICRO-X LTD.
  SUBSTANTIALLY EQUIVALENT 1
MINXRAY, INC
  SUBSTANTIALLY EQUIVALENT 3
MINXRAY, INC.
  SUBSTANTIALLY EQUIVALENT 2
NANJING PERLOVE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANO-X IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUF INC.
  SUBSTANTIALLY EQUIVALENT 1
OEHM UND REHBEIN GMBH
  SUBSTANTIALLY EQUIVALENT 1
OXOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS INDIA LIMITED
  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 3
SEDECAL, SA.
  SUBSTANTIALLY EQUIVALENT 1
SEDECAL., SA.
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI)
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOLUTIONS FOR TOMORROW AB
  SUBSTANTIALLY EQUIVALENT 1
STEPHANIX
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VMI TECNOLOGIAS LTDA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 35 35
2018 27 27
2019 40 40
2020 48 48
2021 47 49

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 36 38
Unintended Movement 33 33
Use of Device Problem 17 17
Detachment of Device or Device Component 15 15
Improper or Incorrect Procedure or Method 13 13
Break 12 12
Mechanical Problem 11 11
Smoking 11 11
Device Operational Issue 9 9
No Display/Image 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 7 7
Electrical /Electronic Property Problem 6 6
Fire 6 6
Image Display Error/Artifact 5 5
Device Handling Problem 5 5
Device Fell 5 5
Material Integrity Problem 5 5
Device Displays Incorrect Message 5 5
Device Operates Differently Than Expected 4 4
Therapeutic or Diagnostic Output Failure 4 4
Positioning Problem 4 4
Thermal Decomposition of Device 4 4
Unintended Collision 4 4
Self-Activation or Keying 3 3
Device Emits Odor 3 3
Computer Software Problem 3 3
Labelling, Instructions for Use or Training Problem 3 3
Loose or Intermittent Connection 3 3
Human-Device Interface Problem 3 3
Material Deformation 2 2
Failure to Shut Off 2 2
Sparking 2 2
Battery Problem 2 2
Inadequate or Insufficient Training 2 2
Device Inoperable 2 2
Arcing 2 2
Misassembly During Maintenance/Repair 2 2
Data Problem 2 2
Patient Data Problem 2 2
Detachment Of Device Component 2 2
Component Falling 2 2
Poor Quality Image 2 2
Device Slipped 2 2
Material Separation 1 1
Component Missing 1 1
Device Issue 1 1
Failure to Align 1 1
Migration or Expulsion of Device 1 1
No Device Output 1 1
Loss of Power 1 1
Product Quality Problem 1 1
Use of Incorrect Control Settings 1 1
Crack 1 1
Device Alarm System 1 1
Premature Discharge of Battery 1 1
Device Maintenance Issue 1 1
Material Frayed 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Wireless Communication Problem 1 1
Protective Measures Problem 1 1
Reset Problem 1 1
Temperature Problem 1 1
Output Problem 1 1
Defective Device 1 1
Connection Problem 1 1
Loss of Data 1 1
Difficult to Advance 1 1
Device Dislodged or Dislocated 1 1
Device Misassembled During Manufacturing /Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 53 53
No Clinical Signs, Symptoms or Conditions 31 32
No Consequences Or Impact To Patient 29 29
Insufficient Information 14 15
No Patient Involvement 10 10
Radiation Exposure, Unintended 10 10
Bone Fracture(s) 9 9
Death 6 6
No Information 6 6
Bruise/Contusion 5 5
Crushing Injury 4 4
Patient Problem/Medical Problem 3 3
Unintended Radiation Exposure 3 3
No Code Available 3 3
Superficial (First Degree) Burn 2 2
Hematoma 2 2
Unspecified Infection 2 2
Laceration(s) 2 2
Pain 2 2
Pneumothorax 2 2
Radiation Burn 1 1
Cardiac Arrest 1 1
Fall 1 1
Fatigue 1 1
Fracture, Arm 1 1
Chemical Exposure 1 1
Unspecified Respiratory Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Healthcare Corp. II Mar-29-2017
2 Carestream Health Inc II Jun-19-2017
3 Carestream Health Inc II Feb-03-2017
4 Fujifilm Medical Systems U.S.A., Inc. II Aug-30-2019
5 Fujifilm Medical Systems U.S.A., Inc. II Mar-21-2019
6 GE Healthcare, LLC II Sep-29-2021
7 NeuroLogica Corporation II May-30-2019
8 Philips Healthcare Inc. II Apr-04-2017
9 Shimadzu Medical Systems II Dec-04-2020
10 Shimadzu Medical Systems Usa Com II Mar-21-2019
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