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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 2
CARESTREAM HEALTH, INC
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 5
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
DEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
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
MEDICATECH USA
  SUBSTANTIALLY EQUIVALENT 1
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 2
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RADMEDIX LLC
  SUBSTANTIALLY EQUIVALENT 2
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
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
2019 77 77
2020 41 41
2021 37 37
2022 27 27
2023 39 39
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 62 62
Use of Device Problem 38 38
Detachment of Device or Device Component 22 22
Device Fell 19 19
Unintended System Motion 16 16
Device Handling Problem 12 12
Unintended Movement 12 12
Mechanical Problem 8 8
Improper or Incorrect Procedure or Method 7 7
Computer Software Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Radiation Overexposure 6 6
Installation-Related Problem 5 5
Poor Quality Image 4 4
No Display/Image 4 4
Problem with Software Installation 4 4
Therapeutic or Diagnostic Output Failure 3 3
Radiation Output Problem 3 3
Unintended Collision 3 3
Fire 3 3
Loss of Data 3 3
Break 3 3
Device Slipped 3 3
Device Tipped Over 2 2
Device Displays Incorrect Message 2 2
Use of Incorrect Control/Treatment Settings 2 2
Display or Visual Feedback Problem 2 2
Activation Failure 2 2
Protective Measures Problem 2 2
Misassembled During Installation 2 2
Key or Button Unresponsive/not Working 1 1
Positioning Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Data Problem 1 1
Noise, Audible 1 1
Fail-Safe Did Not Operate 1 1
Unintended Electrical Shock 1 1
Electrical /Electronic Property Problem 1 1
Energy Output Problem 1 1
Self-Activation or Keying 1 1
Material Separation 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Difficult or Delayed Positioning 1 1
Unintended Power Up 1 1
Flaked 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Application Program Problem 1 1
Defective Component 1 1
Failure to Align 1 1
Arcing 1 1
Activation, Positioning or Separation Problem 1 1
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
No Fail-Safe Mechanism 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67 67
Radiation Exposure, Unintended 56 56
No Known Impact Or Consequence To Patient 19 19
No Consequences Or Impact To Patient 17 17
Insufficient Information 9 9
No Patient Involvement 6 6
Radiation Overdose 6 6
Laceration(s) 5 5
Injury 5 5
Unintended Radiation Exposure 5 5
Patient Problem/Medical Problem 4 4
Crushing Injury 4 4
Unspecified Tissue Injury 4 4
Pain 3 3
Abrasion 3 3
Bruise/Contusion 3 3
Fall 3 3
Bone Fracture(s) 3 3
Head Injury 3 3
Electric Shock 3 3
Suture Abrasion 2 2
Swelling/ Edema 2 2
Tissue Damage 2 2
Concussion 1 1
Tachycardia 1 1
Death 1 1
Eye Injury 1 1
Overdose 1 1
Hematoma 1 1
Hemorrhage, Subdural 1 1
Radiation Burn 1 1
Contusion 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Limb Fracture 1 1
Muscle/Tendon Damage 1 1
Anxiety 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agfa-Gevaert, N.V. II Jan-07-2019
2 Arcoma AB II Jul-05-2022
3 Carestream Health, Inc. II Mar-02-2023
4 Carestream Health, Inc. II Jan-13-2020
5 Cuattro LLC II May-08-2020
6 EOS Imaging II Apr-13-2021
7 GE Hangwei Medical Systems, Co. LTD II Dec-14-2023
8 GE Healthcare, LLC II Sep-20-2019
9 GE Healthcare, LLC II Jun-10-2019
10 Philips Healthcare II Sep-20-2019
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 Mar-23-2019
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 Shanghai United Imaging Healthcare Co., Ltd. II Jul-08-2020
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
25 Siemens Medical Solutions USA, Inc II Aug-05-2020
26 Siemens Medical Solutions USA, Inc II May-05-2020
27 Siemens Medical Solutions USA, Inc II Mar-03-2020
28 Siemens Medical Solutions USA, Inc II Feb-20-2020
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