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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, 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
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 38 38
Device Fell 32 32
Device Handling Problem 24 24
Detachment of Device or Device Component 21 21
Use of Device Problem 16 16
Unintended System Motion 16 16
Mechanical Problem 10 10
Unintended Movement 8 8
Poor Quality Image 6 6
Improper or Incorrect Procedure or Method 6 6
Radiation Overexposure 6 6
Installation-Related Problem 5 5
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
Computer Software Problem 3 3
Activation Failure 3 3
Device Slipped 2 2
Break 2 2
Energy Output Problem 2 2
Display or Visual Feedback Problem 2 2
Misassembled During Installation 2 2
Use of Incorrect Control/Treatment Settings 2 2
Protective Measures Problem 2 2
Noise, Audible 1 1
Mechanical Jam 1 1
Loss of Data 1 1
Device Displays Incorrect Message 1 1
Flaked 1 1
Electrical /Electronic Property Problem 1 1
Self-Activation or Keying 1 1
Naturally Worn 1 1
Appropriate Term/Code Not Available 1 1
Device Dislodged or Dislocated 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 Setup or Prepare 1 1
Key or Button Unresponsive/not Working 1 1
Patient Device Interaction Problem 1 1
No Fail-Safe Mechanism 1 1
Material Integrity Problem 1 1
Fail-Safe Did Not Operate 1 1
Application Program Problem 1 1
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 89 89
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
Bone Fracture(s) 3 3
Injury 3 3
Laceration(s) 3 3
Pain 3 3
Bruise/Contusion 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Electric Shock 2 2
Head Injury 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
Fatigue 1 1
Skin Inflammation/ Irritation 1 1
Dry Eye(s) 1 1
Hematoma 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
Radiation Overdose 1 1
Tissue Damage 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 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 Jul-12-2022
13 Philips Medical Systems Nederland B.V. II Sep-07-2023
14 Philips North America, LLC II Apr-28-2020
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 Shanghai United Imaging Healthcare Co., Ltd. II Jul-08-2020
23 Siemens Medical Solutions USA, Inc II Apr-05-2022
24 Siemens Medical Solutions USA, Inc II Mar-30-2022
25 Siemens Medical Solutions USA, Inc II Apr-02-2021
26 Siemens Medical Solutions USA, Inc II Aug-05-2020
27 Siemens Medical Solutions USA, Inc II May-05-2020
28 Siemens Medical Solutions USA, Inc II Mar-03-2020
29 Siemens Medical Solutions USA, Inc II Feb-20-2020
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