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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 HEALTHCARE N.V.
  SUBSTANTIALLY EQUIVALENT 1
AGFA N.V.
  SUBSTANTIALLY EQUIVALENT 1
AJEX MEDITECH., LTD
  SUBSTANTIALLY EQUIVALENT 1
ARIBEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASPENSTATE INC
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 3
CMT MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEXCOWIN CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ECOTRON CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
FIRST SOURCE INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 6
HDT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL SYSTEMS AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUESTIS MACHINE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JOB CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KUB TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MICRO-X LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MICRO-X LTD.
  SUBSTANTIALLY EQUIVALENT 1
MINXRAY, INC
  SUBSTANTIALLY EQUIVALENT 3
MINXRAY, INC.
  SUBSTANTIALLY EQUIVALENT 5
NANJING PERLOVE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANO-X IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUF INC.
  SUBSTANTIALLY EQUIVALENT 2
OEHM UND REHBEIN GMBH
  SUBSTANTIALLY EQUIVALENT 1
OXOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS INDIA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
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 5
SAMSUNG ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEDECAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
SEDECAL SA
  SUBSTANTIALLY EQUIVALENT 10
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
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SKANRAY TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SOLUTIONS FOR TOMORROW AB
  SUBSTANTIALLY EQUIVALENT 1
SOURCE-RAY, INC.
  SUBSTANTIALLY EQUIVALENT 2
STEPHANIX
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU POWERSITE ELECTRIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRANSAMERICAN MEDICAL IMAGING
  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
2014 51 51
2015 30 30
2016 33 33
2017 35 35
2018 27 27
2019 40 40
2020 48 48
2021 47 49
2022 32 32
2023 77 77
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 93 93
Unintended System Motion 45 47
Nonstandard Device 35 35
Computer Operating System Problem 28 28
Use of Device Problem 24 24
Operating System Version or Upgrade Problem 22 22
Detachment of Device or Device Component 20 20
Mechanical Problem 18 18
Break 17 17
Improper or Incorrect Procedure or Method 17 17
Smoking 17 17
Therapeutic or Diagnostic Output Failure 16 16
Unintended Collision 13 13
Electrical /Electronic Property Problem 12 12
Device Operational Issue 12 12
Insufficient Information 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Device Displays Incorrect Message 11 11
Device Fell 10 10
Device Operates Differently Than Expected 9 9
No Display/Image 9 9
Computer Software Problem 8 8
Fire 8 8
Image Display Error/Artifact 7 7
Loose or Intermittent Connection 7 7
Device Emits Odor 7 7
Sparking 7 7
Battery Problem 7 7
Electrical Shorting 7 7
Positioning Problem 6 6
Material Integrity Problem 6 6
Device Handling Problem 6 6
Self-Activation or Keying 6 6
Thermal Decomposition of Device 6 6
Component Falling 5 5
Defective Component 5 5
Difficult or Delayed Activation 5 5
Radiation Overexposure 5 5
Protective Measures Problem 4 4
Output Problem 4 4
Human-Device Interface Problem 4 4
Data Problem 4 4
Arcing 4 4
Device Inoperable 4 4
Unstable 4 4
Device Slipped 3 3
Overheating of Device 3 3
Device Issue 3 3
Detachment Of Device Component 3 3
Degraded 3 3
Poor Quality Image 3 3
Labelling, Instructions for Use or Training Problem 3 3
No Apparent Adverse Event 3 3
Misassembly During Maintenance/Repair 3 3
Failure to Shut Off 3 3
Loss of Data 3 3
Naturally Worn 3 3
Material Deformation 2 2
Temperature Problem 2 2
Inadequate or Insufficient Training 2 2
Device Dislodged or Dislocated 2 2
Radiation Output Failure 2 2
Patient Data Problem 2 2
Activation Failure 2 2
Fracture 2 2
Crack 2 2
Communication or Transmission Problem 2 2
Defective Device 2 2
Loss of Power 2 2
Material Separation 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Product Quality Problem 2 2
Retraction Problem 1 1
Material Rupture 1 1
Device Difficult to Setup or Prepare 1 1
Difficult To Position 1 1
Power Conditioning Problem 1 1
Sticking 1 1
Device Stops Intermittently 1 1
Electro-Static Discharge 1 1
Device Tipped Over 1 1
Connection Problem 1 1
Structural Problem 1 1
Failure to Align 1 1
Failure to Advance 1 1
Low Battery 1 1
Component Missing 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
No Device Output 1 1
Material Frayed 1 1
Entrapment of Device 1 1
Device Maintenance Issue 1 1
Disassembly 1 1
Material Discolored 1 1
Display or Visual Feedback Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Failure to Charge 1 1
Circuit Failure 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 109 109
No Clinical Signs, Symptoms or Conditions 96 97
Insufficient Information 47 48
No Consequences Or Impact To Patient 42 42
No Patient Involvement 20 20
Bone Fracture(s) 16 16
Radiation Exposure, Unintended 12 12
Bruise/Contusion 9 9
No Information 8 8
No Code Available 6 6
Death 6 6
Laceration(s) 6 6
Pain 5 5
Unintended Radiation Exposure 5 5
Not Applicable 4 4
Injury 4 4
Crushing Injury 4 4
Patient Problem/Medical Problem 4 4
Superficial (First Degree) Burn 3 3
Physical Entrapment 3 3
Hematoma 3 3
Fall 3 3
Abrasion 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Tissue Injury 2 2
Fatigue 2 2
Unspecified Infection 2 2
Pneumothorax 2 2
Joint Dislocation 2 2
Skin Tears 2 2
Electric Shock 2 2
Chemical Exposure 1 1
Swelling 1 1
Fracture, Arm 1 1
Arthralgia 1 1
Partial thickness (Second Degree) Burn 1 1
Test Result 1 1
Head Injury 1 1
Muscle Weakness 1 1
Nerve Damage 1 1
Undesired Nerve Stimulation 1 1
Electrocution 1 1
Radiation Overdose 1 1
Radiation Burn 1 1
Cardiac Arrest 1 1
Unspecified Respiratory Problem 1 1
Hyperextension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Corp. II Jul-21-2014
2 AGFA Corp. II Jun-06-2013
3 AGFA Healthcare Corp. II Jun-10-2015
4 AGFA Healthcare Corp. III Aug-10-2014
5 AGFA Healthcare Corp. II Mar-29-2017
6 AGFA US CORP II Apr-02-2024
7 Carestream Health Inc II Jun-19-2017
8 Carestream Health Inc II Feb-03-2017
9 Carestream Health Inc II Dec-16-2014
10 Carestream Health Inc. II Jan-03-2014
11 Carestream Health Inc. II Nov-07-2013
12 Carestream Health Inc. II Nov-01-2013
13 Carestream Health, Inc. II Dec-01-2023
14 Carestream Health, Inc. II Nov-09-2023
15 Carestream Health, Inc. II Jan-21-2014
16 Carestream Health, Inc. II Oct-31-2013
17 Carestream Health, Inc. II Oct-31-2013
18 FUJIFILM Healthcare Americas Corporation II Apr-27-2023
19 Fujifilm Medical Systems U.S.A., Inc. II Aug-30-2019
20 Fujifilm Medical Systems U.S.A., Inc. II Mar-21-2019
21 GE Healthcare II Apr-27-2015
22 GE Healthcare, LLC II Sep-29-2021
23 GE Healthcare, LLC II Jan-11-2014
24 GE Healthcare, LLC II Aug-09-2013
25 GE Healthcare, LLC II Apr-10-2013
26 GE Healthcare, LLC II Nov-29-2012
27 GE Healthcare, LLC II Sep-13-2012
28 GE Healthcare, LLC II Jul-19-2012
29 GE Healthcare, LLC II Apr-24-2012
30 GE Medical Systems, LLC II Feb-08-2016
31 GE OEC Medical Systems, Inc II Aug-01-2012
32 Medtronic Navigation, Inc II Feb-04-2009
33 Medtronic Navigation, Inc. II Jun-21-2012
34 Medtronic Navigation, Inc. II Nov-23-2010
35 Micro-X Ltd. II Sep-23-2022
36 NeuroLogica Corporation II Feb-09-2024
37 NeuroLogica Corporation II Apr-19-2023
38 NeuroLogica Corporation II May-30-2019
39 Philips Healthcare Inc. II Apr-04-2017
40 Philips Healthcare Inc. II Aug-21-2013
41 Philips Healthcare Inc. II Jun-13-2012
42 Philips Healthcare Inc. II May-30-2012
43 Philips Medical Systems North America Co. Phillips II Mar-08-2011
44 Philips Medical Systems, Inc. II Dec-16-2014
45 SEDECAL SA II Feb-14-2024
46 SEDECAL SA II Jun-30-2023
47 SEDECAL SA II Mar-02-2023
48 SEDECAL SA II Nov-04-2022
49 Sedecal S.A. II Mar-08-2016
50 Sedecal S.A. II Aug-14-2015
51 Sedecal S.A. II Feb-02-2015
52 Sedecal USA, Inc. II Jun-03-2016
53 Shimadzu Medical Systems II Dec-04-2020
54 Shimadzu Medical Systems II Dec-18-2015
55 Shimadzu Medical Systems II Mar-07-2014
56 Shimadzu Medical Systems II Jun-03-2013
57 Shimadzu Medical Systems II Nov-08-2012
58 Shimadzu Medical Systems Usa Com II Mar-21-2019
59 Siemens Medical Solutions USA, Inc II Nov-14-2023
60 Siemens Medical Solutions USA, Inc II Jul-02-2014
61 Siemens Medical Solutions USA, Inc II Aug-05-2013
62 Siemens Medical Solutions USA, Inc II Dec-06-2012
63 Siemens Medical Solutions USA, Inc II Sep-11-2012
64 Siemens Medical Solutions USA, Inc II Sep-06-2012
65 Siemens Medical Solutions USA, Inc II Aug-11-2011
66 Siemens Medical Solutions USA, Inc II Dec-17-2010
67 Siemens Medical Solutions USA, Inc II Nov-01-2010
68 Trans American Medical, Inc. II Jan-03-2014
69 Virtual Imaging, Inc. II Feb-09-2015
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