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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, stationary
Product CodeKPR
Regulation Number 892.1680
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCOGENT LLC
  SUBSTANTIALLY EQUIVALENT 1
ADANI
  SUBSTANTIALLY EQUIVALENT 1
AFGA HEALTHCARE N.V.
  SUBSTANTIALLY EQUIVALENT 1
AGFA HEALTHCARE N.V.
  SUBSTANTIALLY EQUIVALENT 2
ALLENGERS MEDICAL SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 3
ARCOMA AB
  SUBSTANTIALLY EQUIVALENT 1
ARQUILLA, INC. DBA X-CEL X-RAY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BEIJING POLYCON MEDICAL ENGINEERING COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BEIJING SINOPHARM HUNDRIC MEDILINE INFO. TECH. CO.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 7
CARESTREAM HEALTH,INC.
  SUBSTANTIALLY EQUIVALENT 1
CHOONGWAE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
CMT MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
COMMUNICATIONS & POWER INDUSTRIES CANADA, INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 2
CONTROL-X MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUATTRO, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
DRTECH CORP.
  SUBSTANTIALLY EQUIVALENT 2
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 4
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 2
GE HUALUN MEDICAL SYSTEMS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
GE HUALUN MEDICAL SYSTEMS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HUALUN MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
GE HUALUN MEDICAL SYSTEMS CO.LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GEMSS HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GEMSS MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HALIFAX BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMASIGHT INC
  SUBSTANTIALLY EQUIVALENT 1
IMIX ADR FINLAND OY
  SUBSTANTIALLY EQUIVALENT 2
JPI HEALTHCARE CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
JPI HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
KONICA MINOLTA HEALTHCARE AMERICAS, INC
  SUBSTANTIALLY EQUIVALENT 3
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
KUB TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH INC.
  SUBSTANTIALLY EQUIVALENT 1
MDI CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICATECH USA
  SUBSTANTIALLY EQUIVALENT 4
MEDIEN INTERNATIONAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NANORAY BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ORICH MEDICAL EQUIPMENT (TIANJIN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSKO, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS HEALTHCARE (SUZHOU) CO., LIT.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 2
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
QUANTUM MEDICAL IMAGING DIVISON OF CARESTREAM
  SUBSTANTIALLY EQUIVALENT 1
RADIOLOGY SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
RADMEDIX LLC
  SUBSTANTIALLY EQUIVALENT 2
ROESYS GMBH
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 16
SAMSUNG ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 3
SEDECAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
SEDECAL SA
  SUBSTANTIALLY EQUIVALENT 1
SEDECAL, SA.
  SUBSTANTIALLY EQUIVALENT 1
SG HEALTHCARE CO LTD
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS MEDICAL SOLUTION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 10
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SKANRAY TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SKANRAY TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SOURCE-RAY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT INDUSTRIES LLC
  SUBSTANTIALLY EQUIVALENT 2
SWISSRAY MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
TELEVERE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISARIS D.O.O. BELGRADE
  SUBSTANTIALLY EQUIVALENT 2
VIZTEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
VMI TECNOLOGIAS LTDA
  SUBSTANTIALLY EQUIVALENT 1
XERA MEDICAL SYSTEMS & TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
XORAN TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 34 34
2015 59 59
2016 18 18
2017 30 30
2018 36 36
2019 77 77
2020 41 41
2021 37 37
2022 27 27
2023 39 39
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 68 68
Unintended Movement 61 61
Use of Device Problem 47 47
Nonstandard Device 36 36
Computer Software Problem 33 33
Detachment of Device or Device Component 23 23
Improper or Incorrect Procedure or Method 21 21
Unintended System Motion 20 20
Device Fell 19 19
Component Falling 18 18
Mechanical Problem 16 16
Device Operates Differently Than Expected 15 15
Device Handling Problem 14 14
Break 13 13
Detachment Of Device Component 12 12
Adverse Event Without Identified Device or Use Problem 10 10
Loose or Intermittent Connection 8 8
Unintended Collision 7 7
Difficult To Position 7 7
Installation-Related Problem 7 7
Radiation Overexposure 7 7
No Display/Image 5 5
Fire 5 5
Self-Activation or Keying 4 4
Poor Quality Image 4 4
Device Slipped 4 4
Failure to Align 4 4
Device Tipped Over 4 4
Problem with Software Installation 4 4
Positioning Problem 4 4
Noise, Audible 4 4
Appropriate Term/Code Not Available 4 4
Insufficient Information 3 3
Protective Measures Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Radiation Output Problem 3 3
Device Displays Incorrect Message 3 3
Physical Resistance 3 3
Loss of Data 3 3
Electrical /Electronic Property Problem 3 3
Use of Incorrect Control/Treatment Settings 3 3
Failure To Adhere Or Bond 2 2
Display or Visual Feedback Problem 2 2
Off-Label Use 2 2
Device Dislodged or Dislocated 2 2
Mechanical Jam 2 2
Application Program Problem 2 2
Sticking 2 2
Device Stops Intermittently 2 2
Defective Component 2 2
Component Missing 2 2
Misassembled During Installation 2 2
Power Problem 2 2
Activation Failure 2 2
Data Problem 2 2
Patient Data Problem 1 1
Operating System Version or Upgrade Problem 1 1
Packaging Problem 1 1
Programming Issue 1 1
Key or Button Unresponsive/not Working 1 1
Fail-Safe Did Not Operate 1 1
Unintended Electrical Shock 1 1
Device Issue 1 1
Structural Problem 1 1
Smoking 1 1
Computer Operating System Problem 1 1
Sparking 1 1
Arcing 1 1
Failure to Advance 1 1
Mechanics Altered 1 1
Naturally Worn 1 1
No Fail-Safe Mechanism 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Failure to Shut Off 1 1
Human-Device Interface Problem 1 1
Incorrect Device Or Component Shipped 1 1
Activation, Positioning or Separation Problem 1 1
Failure to Transmit Record 1 1
Device Remains Activated 1 1
Material Separation 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Difficult to Setup or Prepare 1 1
Energy Output Problem 1 1
Device Emits Odor 1 1
Migration or Expulsion of Device 1 1
Unintended Ejection 1 1
Flaked 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Thermal Decomposition of Device 1 1
Difficult or Delayed Positioning 1 1
Unintended Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 111 111
No Clinical Signs, Symptoms or Conditions 67 67
Radiation Exposure, Unintended 63 63
No Consequences Or Impact To Patient 34 34
Injury 22 22
No Patient Involvement 18 18
Bone Fracture(s) 14 14
Insufficient Information 9 9
Pain 8 8
Fall 8 8
Radiation Overdose 7 7
Bruise/Contusion 6 6
Laceration(s) 6 6
Abrasion 5 5
Electric Shock 5 5
Unintended Radiation Exposure 5 5
Unspecified Tissue Injury 4 4
Crushing Injury 4 4
Head Injury 4 4
Patient Problem/Medical Problem 4 4
Arthralgia 3 3
Tissue Damage 3 3
Contusion 3 3
No Information 3 3
No Code Available 2 2
Swelling/ Edema 2 2
Death 2 2
Discomfort 2 2
Suture Abrasion 2 2
Ambulation Difficulties 1 1
Non-union Bone Fracture 1 1
Tooth Fracture 1 1
Not Applicable 1 1
Complaint, Ill-Defined 1 1
Fracture, Arm 1 1
Misdiagnosis 1 1
Concussion 1 1
Anxiety 1 1
Eye Injury 1 1
Radiation Burn 1 1
Burn(s) 1 1
Hematoma 1 1
Hemorrhage, Subdural 1 1
Muscle Weakness 1 1
Overdose 1 1
Sprain 1 1
Tachycardia 1 1
Limb Fracture 1 1
Muscle/Tendon Damage 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Healthcare Corp. II Aug-10-2014
2 AGFA Healthcare Corp. II Apr-05-2017
3 Agfa N.V. II Sep-25-2018
4 Agfa-Gevaert, N.V. II Jan-07-2019
5 Arcoma AB II Jul-05-2022
6 Carestream Health Inc II Aug-22-2015
7 Carestream Health Inc. II Aug-01-2014
8 Carestream Health Inc. II Jan-29-2014
9 Carestream Health Inc. II Aug-12-2013
10 Carestream Health, Inc. II Mar-02-2023
11 Carestream Health, Inc. II Jan-13-2020
12 Carestream Health, Inc. II Aug-10-2014
13 Carestream Health, Inc. II Jan-27-2014
14 Cuattro LLC II May-08-2020
15 EOS Imaging II Apr-13-2021
16 Fujifilm Medical Systems U.S.A., Inc. II Dec-10-2017
17 GE Hangwei Medical Systems, Co. LTD II Dec-14-2023
18 GE Healthcare II Mar-06-2015
19 GE Healthcare II Jan-12-2015
20 GE Healthcare, LLC II Sep-20-2019
21 GE Healthcare, LLC II Jun-10-2019
22 GE Healthcare, LLC II Jul-16-2018
23 GE Healthcare, LLC II Jul-02-2014
24 GE Healthcare, LLC II Feb-21-2012
25 GE Healthcare, LLC II Jan-11-2012
26 GE Healthcare, LLC II Sep-25-2009
27 GE Medical Systems, LLC II Dec-16-2009
28 GE Medical Systems, LLC II Sep-24-2009
29 GE Medical Systems, LLC II Sep-22-2009
30 General Electric Med Systems LLC II Jun-08-2012
31 NeuroLogica Corporation II Mar-02-2018
32 NeuroLogica Corporation II Aug-25-2017
33 Philips Electronics North America Corporation II Jan-03-2018
34 Philips Electronics North America Corporation II Jun-09-2017
35 Philips Electronics North America Corporation II Sep-01-2016
36 Philips Electronics North America Corporation II Feb-05-2016
37 Philips Healthcare II Sep-20-2019
38 Philips Healthcare II Jun-03-2016
39 Philips Healthcare Inc. II Aug-26-2013
40 Philips Healthcare Inc. II Jun-17-2013
41 Philips Healthcare Inc. II Feb-01-2013
42 Philips Healthcare Inc. II Aug-15-2012
43 Philips Healthcare Inc. II Aug-08-2012
44 Philips Healthcare Inc. II Mar-27-2012
45 Philips Healthcare Inc. II Mar-15-2012
46 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
47 Philips Medical Systems DMC GmbH II Jul-12-2022
48 Philips Medical Systems Nederland B.V. II Sep-07-2023
49 Philips Medical Systems Nederlands II May-03-2018
50 Philips Medical Systems North America Co. Phillips II Nov-26-2010
51 Philips Medical Systems North America Co. Phillips II Oct-07-2010
52 Philips Medical Systems North America Co. Phillips II Oct-06-2010
53 Philips Medical Systems North America Co. Phillips II Sep-14-2010
54 Philips Medical Systems North America Co. Phillips II Aug-10-2010
55 Philips Medical Systems North America Co. Phillips II Mar-23-2010
56 Philips Medical Systems North America Co. Phillips II Sep-25-2009
57 Philips Medical Systems, Inc. II Mar-31-2016
58 Philips Medical Systems, Inc. II Dec-03-2015
59 Philips Medical Systems, Inc. II May-19-2015
60 Philips Medical Systems, Inc. II Mar-06-2015
61 Philips Medical Systems, Inc. II Dec-02-2013
62 Philips North America, LLC II Apr-28-2020
63 Philips North America, LLC II Mar-23-2019
64 Philips North America Llc II Nov-08-2023
65 Philips North America Llc II Apr-12-2023
66 Philips North America Llc II Sep-01-2022
67 SEDECAL SA II Jan-23-2024
68 Shanghai United Imaging Healthcare Co., Ltd. II May-12-2022
69 Shanghai United Imaging Healthcare Co., Ltd. II Mar-02-2021
70 Shanghai United Imaging Healthcare Co., Ltd. II Jul-08-2020
71 Shimadzu Medical Systems Usa Com II Jun-29-2017
72 Siemens Medical Solutions USA, Inc II Apr-05-2022
73 Siemens Medical Solutions USA, Inc II Mar-30-2022
74 Siemens Medical Solutions USA, Inc II Apr-02-2021
75 Siemens Medical Solutions USA, Inc II Aug-05-2020
76 Siemens Medical Solutions USA, Inc II May-05-2020
77 Siemens Medical Solutions USA, Inc II Mar-03-2020
78 Siemens Medical Solutions USA, Inc II Feb-20-2020
79 Siemens Medical Solutions USA, Inc II Oct-30-2018
80 Siemens Medical Solutions USA, Inc II Oct-30-2018
81 Siemens Medical Solutions USA, Inc II Oct-04-2016
82 Siemens Medical Solutions USA, Inc II May-23-2015
83 Siemens Medical Solutions USA, Inc II May-05-2015
84 Siemens Medical Solutions USA, Inc II Jan-16-2015
85 Siemens Medical Solutions USA, Inc II Oct-02-2014
86 Siemens Medical Solutions USA, Inc II Sep-23-2014
87 Siemens Medical Solutions USA, Inc II Jun-21-2014
88 Siemens Medical Solutions USA, Inc II Jun-04-2014
89 Siemens Medical Solutions USA, Inc II Apr-24-2014
90 Siemens Medical Solutions USA, Inc II Nov-26-2013
91 Siemens Medical Solutions USA, Inc II Apr-12-2011
92 Swissray Medical II Sep-25-2018
93 Swissray Medical II Sep-18-2018
94 Visaris DOO II May-15-2018
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