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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
ALLENGERS MEDICAL SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DK MEDICAL SYSTEM
  SUBSTANTIALLY EQUIVALENT 1
DK MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 1
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 2
NANORAY BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 3
RADMEDIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEDECAL., SA.
  SUBSTANTIALLY EQUIVALENT 1
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 4
SKANRAY TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 2
XERA MEDICAL SYSTEMS & TECHNOLOGY , LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 37 38
2022 27 27
2023 39 39
2024 34 35
2025 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 42 42
Device Handling Problem 30 30
Detachment of Device or Device Component 21 22
Device Operational Issue 17 17
Unintended System Motion 16 16
Mechanical Problem 13 13
Use of Device Problem 11 12
Unintended Movement 7 7
Installation-Related Problem 7 7
Poor Quality Image 6 7
Radiation Overexposure 6 6
Improper or Incorrect Procedure or Method 5 5
Display or Visual Feedback Problem 4 4
Unintended Collision 3 3
Unintended Electrical Shock 3 3
Computer Software Problem 3 3
Patient Device Interaction Problem 3 3
Activation Failure 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device Slipped 2 2
Radiation Output Problem 2 2
Break 2 2
Loss of Data 2 3
Flaked 2 2
Protective Measures Problem 2 2
Misassembled During Installation 2 2
Use of Incorrect Control/Treatment Settings 2 2
Noise, Audible 1 2
Mechanical Jam 1 1
Electrical /Electronic Property Problem 1 1
Naturally Worn 1 1
Device Dislodged or Dislocated 1 1
No Apparent Adverse Event 1 1
Material Separation 1 1
Data Problem 1 1
Computer Operating System Problem 1 1
Difficult or Delayed Positioning 1 1
Device Difficult to Setup or Prepare 1 2
Key or Button Unresponsive/not Working 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Fail-Safe Mechanism 1 1
Material Integrity Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Device 1 1
Smoking 1 1
Fail-Safe Did Not Operate 1 1
Insufficient Information 1 1
Energy Output Problem 1 2
Device Tipped Over 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 104 105
Insufficient Information 9 9
Unintended Radiation Exposure 7 8
Radiation Exposure, Unintended 7 7
Pain 5 5
Abrasion 4 4
Crushing Injury 4 4
Unspecified Tissue Injury 4 4
Bruise/Contusion 3 3
Bone Fracture(s) 3 3
Fall 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Electric Shock 2 2
Speech Disorder 2 2
Hallucination 2 2
Nausea 2 2
Head Injury 2 2
Confusion/ Disorientation 2 2
Blurred Vision 2 2
Swelling/ Edema 2 2
Erythema 2 2
Vomiting 2 2
Discomfort 2 2
Hair Loss 2 2
Laceration(s) 2 2
Eye Injury 2 2
Anxiety 2 2
Corneal Scar 1 1
Thrombocytopenia 1 2
Skin Tears 1 1
Tachycardia 1 1
Muscle/Tendon Damage 1 1
Limb Fracture 1 1
Injury 1 1
Epistaxis 1 2
Multiple Fractures 1 1
Dry Eye(s) 1 2
Skin Inflammation/ Irritation 1 2
Fatigue 1 1
Emotional Changes 1 1
Foreign Body Sensation in Eye 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arcoma AB II Jul-05-2022
2 Carestream Health, Inc. II Mar-02-2023
3 EOS Imaging II Apr-13-2021
4 FUJIFILM Healthcare Americas Corporation II Oct-07-2025
5 FUJIFILM Healthcare Americas Corporation II May-24-2024
6 GE Hangwei Medical Systems, Co. LTD II Dec-14-2023
7 GE Healthcare (China) Co., Ltd. II Nov-25-2024
8 GE Healthcare (China) Co., Ltd. II Aug-26-2024
9 GE Medical Systems, LLC II Feb-03-2025
10 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-18-2024
11 Philips Medical Systems DMC GmbH II Nov-07-2025
12 Philips Medical Systems DMC GmbH II Jul-12-2022
13 Philips Medical Systems Nederland B.V. II Sep-07-2023
14 Philips North America Llc II Apr-11-2025
15 Philips North America Llc II Nov-08-2023
16 Philips North America Llc II Apr-12-2023
17 Philips North America Llc II Sep-01-2022
18 SEDECAL SA II Jan-23-2024
19 Shanghai United Imaging Healthcare Co., Ltd. II May-12-2022
20 Shanghai United Imaging Healthcare Co., Ltd. II Mar-02-2021
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
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