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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
ADANI
  SUBSTANTIALLY EQUIVALENT 1
ALLENGERS MEDICAL SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CARESTREAM HEALTH, INC
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 5
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
DEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 3
GE HUALUN MEDICAL SYSTEMS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HUALUN MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GEMSS HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JPI HEALTHCARE CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA HEALTHCARE AMERICAS, INC
  SUBSTANTIALLY EQUIVALENT 3
MEDICATECH USA
  SUBSTANTIALLY EQUIVALENT 1
NANORAY BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE (SUZHOU) CO., LIT.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 3
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RADMEDIX LLC
  SUBSTANTIALLY EQUIVALENT 2
SEDECAL SA
  SUBSTANTIALLY EQUIVALENT 1
SEDECAL, SA.
  SUBSTANTIALLY EQUIVALENT 1
SG HEALTHCARE CO LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SKANRAY TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SKANRAY TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
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
2019 77 77
2020 41 41
2021 37 37
2022 27 27
2023 39 39
2024 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 62 62
Use of Device Problem 40 40
Device Fell 29 29
Detachment of Device or Device Component 22 22
Device Handling Problem 21 21
Unintended System Motion 16 16
Unintended Movement 12 12
Mechanical Problem 8 8
Improper or Incorrect Procedure or Method 7 7
Poor Quality Image 7 7
Computer Software Problem 6 6
Radiation Overexposure 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Installation-Related Problem 5 5
No Display/Image 4 4
Loss of Data 4 4
Problem with Software Installation 4 4
Activation Failure 3 3
Unintended Collision 3 3
Therapeutic or Diagnostic Output Failure 3 3
Fire 3 3
Break 3 3
Radiation Output Problem 3 3
Device Slipped 3 3
Energy Output Problem 2 2
Device Displays Incorrect Message 2 2
Misassembled During Installation 2 2
Display or Visual Feedback Problem 2 2
Protective Measures Problem 2 2
Device Tipped Over 2 2
Use of Incorrect Control/Treatment Settings 2 2
Noise, Audible 2 2
Inappropriate/Inadequate Shock/Stimulation 1 1
Difficult or Delayed Positioning 1 1
Material Separation 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1
Key or Button Unresponsive/not Working 1 1
Mechanical Jam 1 1
Activation, Positioning or Separation Problem 1 1
Arcing 1 1
Flaked 1 1
Application Program Problem 1 1
Failure to Align 1 1
Fail-Safe Did Not Operate 1 1
Positioning Problem 1 1
Material Fragmentation 1 1
Insufficient Information 1 1
Data Problem 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 79 79
Radiation Exposure, Unintended 56 56
No Known Impact Or Consequence To Patient 19 19
No Consequences Or Impact To Patient 17 17
Insufficient Information 9 9
Unintended Radiation Exposure 6 6
No Patient Involvement 6 6
Radiation Overdose 6 6
Laceration(s) 5 5
Injury 5 5
Patient Problem/Medical Problem 4 4
Crushing Injury 4 4
Unspecified Tissue Injury 4 4
Pain 4 4
Fall 3 3
Head Injury 3 3
Bruise/Contusion 3 3
Abrasion 3 3
Electric Shock 3 3
Bone Fracture(s) 3 3
Discomfort 2 2
Swelling/ Edema 2 2
Suture Abrasion 2 2
Tissue Damage 2 2
Concussion 1 1
Radiation Burn 1 1
Hemorrhage, Subdural 1 1
Skin Inflammation/ Irritation 1 1
Fatigue 1 1
Hematoma 1 1
Limb Fracture 1 1
No Code Available 1 1
Muscle/Tendon Damage 1 1
Epistaxis 1 1
Anxiety 1 1
Death 1 1
Tachycardia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Eye Injury 1 1
Overdose 1 1
Dry Eye(s) 1 1
Contusion 1 1
Thrombocytopenia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agfa-Gevaert, N.V. II Jan-07-2019
2 Arcoma AB II Jul-05-2022
3 Carestream Health, Inc. II Mar-02-2023
4 Carestream Health, Inc. II Jan-13-2020
5 Cuattro LLC II May-08-2020
6 EOS Imaging II Apr-13-2021
7 FUJIFILM Healthcare Americas Corporation II May-24-2024
8 GE Hangwei Medical Systems, Co. LTD II Dec-14-2023
9 GE Healthcare (China) Co., Ltd. II Aug-26-2024
10 GE Healthcare, LLC II Sep-20-2019
11 GE Healthcare, LLC II Jun-10-2019
12 Philips Healthcare II Sep-20-2019
13 Philips Medical Systems DMC GmbH II Jul-12-2022
14 Philips Medical Systems Nederland B.V. II Sep-07-2023
15 Philips North America, LLC II Apr-28-2020
16 Philips North America, LLC II Mar-23-2019
17 Philips North America Llc II Nov-08-2023
18 Philips North America Llc II Apr-12-2023
19 Philips North America Llc II Sep-01-2022
20 SEDECAL SA II Jan-23-2024
21 Shanghai United Imaging Healthcare Co., Ltd. II May-12-2022
22 Shanghai United Imaging Healthcare Co., Ltd. II Mar-02-2021
23 Shanghai United Imaging Healthcare Co., Ltd. II Jul-08-2020
24 Siemens Medical Solutions USA, Inc II Apr-05-2022
25 Siemens Medical Solutions USA, Inc II Mar-30-2022
26 Siemens Medical Solutions USA, Inc II Apr-02-2021
27 Siemens Medical Solutions USA, Inc II Aug-05-2020
28 Siemens Medical Solutions USA, Inc II May-05-2020
29 Siemens Medical Solutions USA, Inc II Mar-03-2020
30 Siemens Medical Solutions USA, Inc II Feb-20-2020
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