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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 1
CARESTREAM HEALTH, INC
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 3
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
DEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DK MEDICAL SYSTEM
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 2
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
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
RADMEDIX LLC
  SUBSTANTIALLY EQUIVALENT 2
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
SHENZHEN SONTU MEDICAL IMAGING EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 6
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
2020 41 41
2021 37 37
2022 27 27
2023 39 39
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 37 37
Device Fell 29 29
Device Handling Problem 22 22
Detachment of Device or Device Component 19 19
Unintended System Motion 16 16
Use of Device Problem 16 16
Unintended Movement 8 8
Mechanical Problem 7 7
Improper or Incorrect Procedure or Method 6 6
Poor Quality Image 6 6
Radiation Overexposure 6 6
Installation-Related Problem 5 5
Unintended Collision 3 3
Radiation Output Problem 3 3
Computer Software Problem 3 3
Activation Failure 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Display or Visual Feedback Problem 2 2
Protective Measures Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Misassembled During Installation 2 2
Energy Output Problem 2 2
Unintended Electrical Shock 2 2
Break 2 2
Device Slipped 2 2
Key or Button Unresponsive/not Working 1 1
Device Difficult to Setup or Prepare 1 1
No Fail-Safe Mechanism 1 1
Material Integrity Problem 1 1
Difficult or Delayed Positioning 1 1
Computer Operating System Problem 1 1
Data Problem 1 1
Fail-Safe Did Not Operate 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Separation 1 1
Application Program Problem 1 1
Device Tipped Over 1 1
Device Dislodged or Dislocated 1 1
Fire 1 1
Appropriate Term/Code Not Available 1 1
No Display/Image 1 1
Naturally Worn 1 1
Self-Activation or Keying 1 1
Electrical /Electronic Property Problem 1 1
Flaked 1 1
Activation, Positioning or Separation Problem 1 1
Device Displays Incorrect Message 1 1
Loss of Data 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 81
Radiation Exposure, Unintended 30 30
Insufficient Information 9 9
Unintended Radiation Exposure 7 7
No Consequences Or Impact To Patient 5 5
Crushing Injury 4 4
Unspecified Tissue Injury 4 4
Injury 3 3
Laceration(s) 3 3
Pain 3 3
Bruise/Contusion 3 3
Electric Shock 2 2
Head Injury 2 2
Bone Fracture(s) 2 2
Abrasion 2 2
No Known Impact Or Consequence To Patient 2 2
Discomfort 2 2
Swelling/ Edema 2 2
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Fatigue 1 1
Skin Inflammation/ Irritation 1 1
Hematoma 1 1
Dry Eye(s) 1 1
Suture Abrasion 1 1
Contusion 1 1
Epistaxis 1 1
No Patient Involvement 1 1
Fall 1 1
Eye Injury 1 1
Limb Fracture 1 1
Muscle/Tendon Damage 1 1
Tachycardia 1 1
Anxiety 1 1
Tissue Damage 1 1
Radiation Overdose 1 1
Thrombocytopenia 1 1

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