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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 4
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 2
DEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 2
GE HUALUN MEDICAL SYSTEMS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HUALUN MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HALIFAX BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JPI HEALTHCARE CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA HEALTHCARE AMERICAS, INC
  SUBSTANTIALLY EQUIVALENT 3
LIVERMORETECH INC.
  SUBSTANTIALLY EQUIVALENT 1
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 1
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SAMSUNG ELECTRONICS CO.,LTD.
  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 2
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SKANRAY TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT INDUSTRIES LLC
  SUBSTANTIALLY EQUIVALENT 1
TELEVERE SYSTEMS, INC.
  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
2018 36 36
2019 77 77
2020 41 41
2021 37 37
2022 27 27
2023 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 68 68
Use of Device Problem 42 42
Detachment of Device or Device Component 20 20
Unintended Movement 18 18
Unintended System Motion 13 13
Mechanical Problem 9 9
Improper or Incorrect Procedure or Method 8 8
Computer Software Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Device Fell 7 7
Installation-Related Problem 5 5
Problem with Software Installation 4 4
Break 4 4
Self-Activation or Keying 4 4
Failure to Align 4 4
No Display/Image 3 3
Fire 3 3
Unintended Collision 3 3
Protective Measures Problem 3 3
Radiation Overexposure 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Slipped 3 3
Loss of Data 3 3
Radiation Output Problem 3 3
Appropriate Term/Code Not Available 2 2
Device Handling Problem 2 2
Activation Failure 2 2
Misassembled During Installation 2 2
Mechanical Jam 2 2
Positioning Problem 2 2
Loose or Intermittent Connection 2 2
Display or Visual Feedback Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Device Tipped Over 2 2
Device Displays Incorrect Message 2 2
Defective Component 2 2
Component Missing 2 2
Device Issue 1 1
Energy Output Problem 1 1
Failure to Transmit Record 1 1
Device Remains Activated 1 1
Application Program Problem 1 1
Computer Operating System Problem 1 1
Arcing 1 1
Material Separation 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Unintended Power Up 1 1
Component Falling 1 1
Electrical /Electronic Property Problem 1 1
Unintended Ejection 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Migration or Expulsion of Device 1 1
Poor Quality Image 1 1
Nonstandard Device 1 1
Power Problem 1 1
Insufficient Information 1 1
Naturally Worn 1 1
No Fail-Safe Mechanism 1 1
Material Integrity Problem 1 1
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1
Key or Button Unresponsive/not Working 1 1
Noise, Audible 1 1
Data Problem 1 1
Fail-Safe Did Not Operate 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 62 62
No Clinical Signs, Symptoms or Conditions 44 44
No Known Impact Or Consequence To Patient 35 35
No Consequences Or Impact To Patient 22 22
Injury 8 8
No Patient Involvement 8 8
Insufficient Information 8 8
Radiation Overdose 7 7
Bone Fracture(s) 7 7
Unintended Radiation Exposure 5 5
Laceration(s) 4 4
Patient Problem/Medical Problem 4 4
Unspecified Tissue Injury 4 4
Electric Shock 3 3
Pain 3 3
Head Injury 3 3
Bruise/Contusion 3 3
Crushing Injury 3 3
Fall 3 3
Contusion 2 2
Abrasion 2 2
Suture Abrasion 2 2
Tissue Damage 2 2
Swelling/ Edema 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Concussion 1 1
Anxiety 1 1
Tooth Fracture 1 1
No Information 1 1
No Code Available 1 1
Limb Fracture 1 1
Radiation Burn 1 1
Death 1 1
Eye Injury 1 1
Hematoma 1 1
Hemorrhage, Subdural 1 1
Tachycardia 1 1
Overdose 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agfa N.V. II Sep-25-2018
2 Agfa-Gevaert, N.V. II Jan-07-2019
3 Arcoma AB II Jul-05-2022
4 Carestream Health, Inc. II Mar-02-2023
5 Carestream Health, Inc. II Jan-13-2020
6 Cuattro LLC II May-08-2020
7 EOS Imaging II Apr-13-2021
8 GE Healthcare, LLC II Sep-20-2019
9 GE Healthcare, LLC II Jun-10-2019
10 GE Healthcare, LLC II Jul-16-2018
11 NeuroLogica Corporation II Mar-02-2018
12 Philips Electronics North America Corporation II Jan-03-2018
13 Philips Healthcare II Sep-20-2019
14 Philips Medical Systems DMC GmbH II Jul-12-2022
15 Philips Medical Systems Nederland B.V. II Sep-07-2023
16 Philips Medical Systems Nederlands II May-03-2018
17 Philips North America, LLC II Apr-28-2020
18 Philips North America, LLC II Mar-23-2019
19 Philips North America Llc II Apr-12-2023
20 Philips North America Llc II Sep-01-2022
21 Shanghai United Imaging Healthcare Co., Ltd. II May-12-2022
22 Shanghai United Imaging Healthcare Co., Ltd. II Mar-02-2021
23 Shanghai United Imaging Healthcare Co., Ltd. II Jul-08-2020
24 Siemens Medical Solutions USA, Inc II Apr-05-2022
25 Siemens Medical Solutions USA, Inc II Mar-30-2022
26 Siemens Medical Solutions USA, Inc II Apr-02-2021
27 Siemens Medical Solutions USA, Inc II Aug-05-2020
28 Siemens Medical Solutions USA, Inc II May-05-2020
29 Siemens Medical Solutions USA, Inc II Mar-03-2020
30 Siemens Medical Solutions USA, Inc II Feb-20-2020
31 Siemens Medical Solutions USA, Inc II Oct-30-2018
32 Siemens Medical Solutions USA, Inc II Oct-30-2018
33 Swissray Medical II Sep-25-2018
34 Swissray Medical II Sep-18-2018
35 Visaris DOO II May-15-2018
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