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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
  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 2
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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 2
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 2
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 5
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
2026 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 41 41
Device Handling Problem 31 31
Detachment of Device or Device Component 23 24
Device Operational Issue 18 18
Unintended System Motion 16 16
Mechanical Problem 12 12
Mechanical Jam 11 11
Use of Device Problem 11 11
Installation-Related Problem 10 10
Radiation Overexposure 9 9
Improper or Incorrect Procedure or Method 5 5
Poor Quality Image 5 5
Unintended Movement 5 5
Unintended Collision 4 4
Display or Visual Feedback Problem 4 4
Flaked 3 3
Unintended Electrical Shock 3 3
Computer Software Problem 3 3
Activation Failure 3 3
Patient Device Interaction Problem 3 3
Electrical /Electronic Property Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Insufficient Device Problem Information 2 2
Device Difficult to Maintain 2 2
Key or Button Unresponsive/not Working 2 2
Break 2 2
Radiation Output Problem 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Difficult or Delayed Positioning 1 1
Computer Operating System Problem 1 1
Misassembly by Users 1 1
Misassembled During Installation 1 1
Material Separation 1 1
No Fail-Safe Mechanism 1 1
Material Integrity Problem 1 1
No Apparent Adverse Event 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Smoking 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1
Image Orientation Incorrect 1 1
Fail-Safe Did Not Operate 1 1
Naturally Worn 1 1
Device Tipped Over 1 1
Fire 1 1
No Display/Image 1 1
Loose or Intermittent Connection 1 1
Loss of Data 1 1
Unexpected/Unintended Radiation Output 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 124 125
Pain 12 12
Insufficient Information 9 9
Unintended Radiation Exposure 7 8
Radiation Exposure, Unintended 7 7
Muscle/Tendon Damage 7 7
Crushing Injury 5 5
Abrasion 4 4
Unspecified Tissue Injury 4 4
Fall 4 4
Laceration(s) 4 4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 3 3
Bruise/Contusion 3 3
Bone Fracture(s) 3 3
Anxiety 3 3
Electric Shock 2 2
Speech Disorder 2 2
Emotional Changes 2 2
Nausea 2 2
Hallucination 2 2
Head Injury 2 2
Myalgia 2 2
Confusion/ Disorientation 2 2
Blurred Vision 2 2
Swelling/ Edema 2 2
Neck Pain 2 2
Erythema 2 2
Vomiting 2 2
Discomfort 2 2
Hair Loss 2 2
Eye Injury 2 2
Corneal Scar 1 1
Thrombocytopenia 1 2
Skin Tears 1 1
Tachycardia 1 1
Limb Pain 1 1
Limb Fracture 1 1
Concussion 1 1
Injury 1 1
Back pain 1 1
Tendinopathy 1 1
Epistaxis 1 2
Eye Irritation 1 1
Multiple Fractures 1 1
Dry Eye(s) 1 2
Skin Inflammation/ Irritation 1 2
Fatigue 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 Feb-05-2026
5 FUJIFILM Healthcare Americas Corporation II Oct-07-2025
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 GE Medical Systems, LLC II Feb-03-2025
11 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-18-2024
12 Philips Medical Systems DMC GmbH II Nov-07-2025
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-11-2025
16 Philips North America Llc II Nov-08-2023
17 Philips North America Llc II Apr-12-2023
18 Philips North America Llc II Sep-01-2022
19 SEDECAL SA II Jan-23-2024
20 Shanghai United Imaging Healthcare Co., Ltd. II May-12-2022
21 Shanghai United Imaging Healthcare Co., Ltd. II Mar-02-2021
22 Siemens Medical Solutions USA, Inc II Apr-05-2022
23 Siemens Medical Solutions USA, Inc II Mar-30-2022
24 Siemens Medical Solutions USA, Inc II Apr-02-2021
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