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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
Regulation Description Stationary x-ray system.
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
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 4
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
DK MEDICAL SYSTEMS CO., LTD.
  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 3
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 2
SG HEALTHCARE CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN SONTU MEDICAL IMAGING EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 6
SKANRAY TECHNOLOGIES LIMITED
  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
2020 41 42
2021 37 38
2022 27 27
2023 39 39
2024 34 35
2025 40 40
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 45 45
Device Operational Issue 40 40
Device Handling Problem 30 30
Detachment of Device or Device Component 24 25
Unintended System Motion 17 17
Use of Device Problem 17 18
Mechanical Problem 14 14
Installation-Related Problem 10 10
Unintended Movement 8 8
Poor Quality Image 6 7
Improper or Incorrect Procedure or Method 6 6
Radiation Overexposure 6 6
Display or Visual Feedback Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Radiation Output Problem 3 3
Unintended Collision 3 3
Unintended Electrical Shock 3 3
Therapeutic or Diagnostic Output Failure 3 3
Patient Device Interaction Problem 3 3
Computer Software Problem 3 3
Activation Failure 3 3
Device Slipped 2 2
Break 2 2
Loss of Data 2 3
Energy Output Problem 2 3
Flaked 2 2
Electrical /Electronic Property Problem 2 2
Misassembled During Installation 2 2
Protective Measures Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Noise, Audible 1 2
Mechanical Jam 1 1
Device Displays Incorrect Message 1 1
Self-Activation or Keying 1 2
Naturally Worn 1 1
Appropriate Term/Code Not Available 1 1
Device Dislodged or Dislocated 1 1
No Apparent Adverse Event 1 1
Material Separation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Data Problem 1 1
Computer Operating System Problem 1 1
Difficult or Delayed Positioning 1 1
Device Difficult to Maintain 1 1
Device Difficult to Setup or Prepare 1 2
Key or Button Unresponsive/not Working 1 1
No Fail-Safe Mechanism 1 1
Material Integrity Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 109 110
Radiation Exposure, Unintended 30 30
Insufficient Information 10 10
Unintended Radiation Exposure 7 8
Pain 6 6
No Consequences Or Impact To Patient 5 5
Abrasion 5 5
Unspecified Tissue Injury 4 4
Fall 4 4
Crushing Injury 4 4
Bruise/Contusion 3 3
Anxiety 3 3
Bone Fracture(s) 3 3
Laceration(s) 3 3
Injury 3 3
Hallucination 2 2
Blurred Vision 2 2
Swelling/ Edema 2 2
Eye Injury 2 2
Hair Loss 2 2
Vomiting 2 2
Erythema 2 2
Discomfort 2 2
Confusion/ Disorientation 2 2
No Known Impact Or Consequence To Patient 2 3
Head Injury 2 2
Emotional Changes 2 2
Nausea 2 2
Speech Disorder 2 2
Electric Shock 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Patient Involvement 1 1
Epistaxis 1 2
Contusion 1 1
Suture Abrasion 1 1
Multiple Fractures 1 1
Dry Eye(s) 1 2
Hematoma 1 1
Skin Inflammation/ Irritation 1 2
Limb Fracture 1 1
Muscle/Tendon Damage 1 1
Tachycardia 1 1
Fatigue 1 1
Tissue Damage 1 1
Radiation Overdose 1 1
Thrombocytopenia 1 2
Skin Tears 1 1
Corneal Scar 1 1
Foreign Body Sensation in Eye 1 1
Patient Problem/Medical Problem 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 Feb-05-2026
7 FUJIFILM Healthcare Americas Corporation II Oct-07-2025
8 FUJIFILM Healthcare Americas Corporation II May-24-2024
9 GE Hangwei Medical Systems, Co. LTD II Dec-14-2023
10 GE Healthcare (China) Co., Ltd. II Nov-25-2024
11 GE Healthcare (China) Co., Ltd. II Aug-26-2024
12 GE Medical Systems, LLC II Feb-03-2025
13 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-18-2024
14 Philips Medical Systems DMC GmbH II Nov-07-2025
15 Philips Medical Systems DMC GmbH II Jul-12-2022
16 Philips Medical Systems Nederland B.V. II Sep-07-2023
17 Philips North America, LLC II Apr-28-2020
18 Philips North America Llc II Apr-11-2025
19 Philips North America Llc II Nov-08-2023
20 Philips North America Llc II Apr-12-2023
21 Philips North America Llc II Sep-01-2022
22 SEDECAL SA II Jan-23-2024
23 Shanghai United Imaging Healthcare Co., Ltd. II May-12-2022
24 Shanghai United Imaging Healthcare Co., Ltd. II Mar-02-2021
25 Shanghai United Imaging Healthcare Co., Ltd. II Jul-08-2020
26 Siemens Medical Solutions USA, Inc II Apr-05-2022
27 Siemens Medical Solutions USA, Inc II Mar-30-2022
28 Siemens Medical Solutions USA, Inc II Apr-02-2021
29 Siemens Medical Solutions USA, Inc II Aug-05-2020
30 Siemens Medical Solutions USA, Inc II May-05-2020
31 Siemens Medical Solutions USA, Inc II Mar-03-2020
32 Siemens Medical Solutions USA, Inc II Feb-20-2020
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