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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
Poor Quality Image 7 7
Improper or Incorrect Procedure or Method 7 7
Radiation Overexposure 6 6
Computer Software Problem 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
Unintended Collision 3 3
Therapeutic or Diagnostic Output Failure 3 3
Activation Failure 3 3
Fire 3 3
Break 3 3
Radiation Output Problem 3 3
Device Slipped 3 3
Misassembled During Installation 2 2
Device Displays Incorrect Message 2 2
Display or Visual Feedback Problem 2 2
Energy Output Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Device Tipped Over 2 2
Protective Measures Problem 2 2
Noise, Audible 2 2
Loose or Intermittent Connection 1 1
Human-Device Interface Problem 1 1
Naturally Worn 1 1
Arcing 1 1
Mechanical Jam 1 1
Material Integrity Problem 1 1
Flaked 1 1
Defective Component 1 1
Positioning Problem 1 1
No Fail-Safe Mechanism 1 1
Electrical /Electronic Property Problem 1 1
Self-Activation or Keying 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Material Separation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Data 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
Radiation Overdose 6 6
No Patient Involvement 6 6
Laceration(s) 5 5
Injury 5 5
Patient Problem/Medical Problem 4 4
Unspecified Tissue Injury 4 4
Pain 4 4
Crushing Injury 4 4
Bruise/Contusion 3 3
Fall 3 3
Abrasion 3 3
Head Injury 3 3
Bone Fracture(s) 3 3
Electric Shock 3 3
Suture Abrasion 2 2
Discomfort 2 2
Swelling/ Edema 2 2
Tissue Damage 2 2
Contusion 1 1
Hemorrhage, Subdural 1 1
Overdose 1 1
Epistaxis 1 1
Concussion 1 1
Hematoma 1 1
Dry Eye(s) 1 1
Skin Inflammation/ Irritation 1 1
Eye Injury 1 1
Limb Fracture 1 1
Muscle/Tendon Damage 1 1
Tachycardia 1 1
Anxiety 1 1
No Code Available 1 1
Fatigue 1 1
Radiation Burn 1 1
Thrombocytopenia 1 1
Death 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 MEDICAL SYSTEMS NEDERLAND B.V. II Sep-18-2024
13 Philips Healthcare II Sep-20-2019
14 Philips Medical Systems DMC GmbH II Jul-12-2022
15 Philips Medical Systems Nederland B.V. II Sep-07-2023
16 Philips North America, LLC II Apr-28-2020
17 Philips North America, LLC II Mar-23-2019
18 Philips North America Llc II Nov-08-2023
19 Philips North America Llc II Apr-12-2023
20 Philips North America Llc II Sep-01-2022
21 SEDECAL SA II Jan-23-2024
22 Shanghai United Imaging Healthcare Co., Ltd. II May-12-2022
23 Shanghai United Imaging Healthcare Co., Ltd. II Mar-02-2021
24 Shanghai United Imaging Healthcare Co., Ltd. II Jul-08-2020
25 Siemens Medical Solutions USA, Inc II Apr-05-2022
26 Siemens Medical Solutions USA, Inc II Mar-30-2022
27 Siemens Medical Solutions USA, Inc II Apr-02-2021
28 Siemens Medical Solutions USA, Inc II Aug-05-2020
29 Siemens Medical Solutions USA, Inc II May-05-2020
30 Siemens Medical Solutions USA, Inc II Mar-03-2020
31 Siemens Medical Solutions USA, Inc II Feb-20-2020
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