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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
Regulation Description Mobile x-ray system.
Product CodeIZL
Regulation Number 892.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
Carestream Health Inc.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEL MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 3
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MERIDIAN MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
Minxray Inc
  SUBSTANTIALLY EQUIVALENT 2
OEHM UND REHBEIN GMBH
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SAMSUNG ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEDECAL SA
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SOLUTIONS FOR TOMORROW AB
  SUBSTANTIALLY EQUIVALENT 1
SOURCE-RAY, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE KRETCHMER CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 33 33
2017 35 35
2018 27 27
2019 40 40
2020 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 32 32
Unintended System Motion 20 20
Use of Device Problem 17 17
Break 13 13
Improper or Incorrect Procedure or Method 12 12
Smoking 11 11
Detachment of Device or Device Component 10 10
Adverse Event Without Identified Device or Use Problem 8 8
Device Operational Issue 7 7
No Display/Image 7 7
Fire 7 7
Device Component Or Accessory 7 7
Insufficient Information 7 7
Mechanical Problem 6 6
Device Operates Differently Than Expected 6 6
Screw 5 5
Device Handling Problem 5 5
Device Fell 5 5
Device Displays Incorrect Message 5 5
Image Display Error/Artifact 5 5
Unintended Collision 4 4
Self-Activation or Keying 4 4
Component Falling 4 4
Electrical /Electronic Property Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Device Emits Odor 4 4
Cable, Electrical 3 3
Device Slipped 3 3
Failure to Shut Off 3 3
Device Issue 3 3
Sparking 3 3
Thermal Decomposition of Device 3 3
Power Cord 3 3
Poor Quality Image 3 3
Battery Problem 3 3
Electrical Shorting 3 3
Device Inoperable 3 3
Material Integrity Problem 3 3
Misassembly During Maintenance/Repair 2 2
Arcing 2 2
Loose or Intermittent Connection 2 2
Battery 2 2
Plug 2 2
Collimator 2 2
Cover 2 2
Detachment Of Device Component 2 2
Screen 2 2
Computer Software Problem 2 2
Temperature Problem 2 2
Overheating of Device 2 2
Cap 2 2
Collapse 1 1
Crack 1 1
Bolt 1 1
Brake 1 1
Cord 1 1
Generator 1 1
Unintended Arm Motion 1 1
Bent 1 1
No Device Output 1 1
Migration or Expulsion of Device 1 1
Fracture 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loss of Power 1 1
Device Difficult to Setup or Prepare 1 1
Material Separation 1 1
Failure to Align 1 1
Defective Device 1 1
Human-Device Interface Problem 1 1
Output Problem 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Function Indicator Light 1 1
Wheel 1 1
Misassembly by Users 1 1
Washer 1 1
Noise, Audible 1 1
Wireless Communication Problem 1 1
Material Discolored 1 1
Material Frayed 1 1
Device Alarm System 1 1
Premature Discharge of Battery 1 1
Hinge 1 1
Pin 1 1
User Interface 1 1
Switches 1 1
Device Maintenance Issue 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Improper Device Output 1 1
Connection Problem 1 1
Loss of Data 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Advance 1 1
Positioning Problem 1 1
Reset Problem 1 1
Emergency Button Or Switch 1 1
Motor Drive Unit 1 1
Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 66 66
No Consequences Or Impact To Patient 30 30
No Patient Involvement 16 16
Radiation Exposure, Unintended 11 11
Bone Fracture(s) 10 10
No Clinical Signs, Symptoms or Conditions 9 9
No Information 8 8
Death 6 6
Bruise/Contusion 5 5
No Code Available 4 4
Patient Problem/Medical Problem 4 4
Not Applicable 3 3
Pneumothorax 2 2
Unspecified Infection 2 2
Laceration(s) 2 2
Insufficient Information 2 2
Joint Dislocation 2 2
Hematoma 2 2
Swelling 1 1
Physical Entrapment 1 1
Fracture, Arm 1 1
Abrasion 1 1
Radiation Burn 1 1
Fall 1 1
Fatigue 1 1
Skin Tears 1 1
Unspecified Respiratory Problem 1 1
Unintended Radiation Exposure 1 1
Pain 1 1
Cardiac Arrest 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 Medical Systems, LLC II Feb-08-2016
7 NeuroLogica Corporation II May-30-2019
8 Philips Healthcare Inc. II Apr-04-2017
9 Sedecal S.A. II Mar-08-2016
10 Sedecal USA, Inc. II Jun-03-2016
11 Shimadzu Medical Systems II Dec-04-2020
12 Shimadzu Medical Systems Usa Com II Mar-21-2019
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