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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
ARQUILLA, INC. DBA X-CEL X-RAY CORPORATION
  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 2
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 2
GE HUALUN MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
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 2
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 3
SEDECAL SA
  SUBSTANTIALLY EQUIVALENT 1
SEDECAL, SA.
  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
2017 30 30
2018 36 36
2019 77 77
2020 41 41
2021 37 37
2022 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 68 68
Use of Device Problem 41 41
Unintended Movement 16 16
Improper or Incorrect Procedure or Method 13 13
Detachment of Device or Device Component 12 12
Adverse Event Without Identified Device or Use Problem 9 9
Mechanical Problem 9 9
Unintended System Motion 8 8
Computer Software Problem 7 7
Installation-Related Problem 5 5
Failure to Align 4 4
Problem with Software Installation 4 4
Device Fell 4 4
Component Falling 4 4
No Display/Image 4 4
Loose or Intermittent Connection 4 4
Self-Activation or Keying 4 4
Unintended Collision 3 3
Detachment Of Device Component 3 3
Radiation Output Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Slipped 3 3
Loss of Data 3 3
Mechanical Jam 2 2
Device Operates Differently Than Expected 2 2
Positioning Problem 2 2
Misassembled During Installation 2 2
Appropriate Term/Code Not Available 2 2
Protective Measures Problem 2 2
Failure To Adhere Or Bond 2 2
Break 2 2
Display or Visual Feedback Problem 2 2
Fire 2 2
Off-Label Use 2 2
Defective Component 2 2
Component Missing 2 2
Device Tipped Over 2 2
Device Displays Incorrect Message 2 2
Application Program Problem 1 1
Computer Operating System Problem 1 1
Device Issue 1 1
Structural Problem 1 1
Failure to Transmit Record 1 1
Device Remains Activated 1 1
Material Separation 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Energy Output Problem 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Use of Incorrect Control Settings 1 1
Unintended Power Up 1 1
Migration or Expulsion of Device 1 1
Poor Quality Image 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Electrical /Electronic Property Problem 1 1
Unintended Ejection 1 1
Thermal Decomposition of Device 1 1
Radiation Overexposure 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Power Problem 1 1
Packaging Problem 1 1
Arcing 1 1
Device Dislodged or Dislocated 1 1
Failure to Shut Off 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 63 63
No Known Impact Or Consequence To Patient 43 43
No Consequences Or Impact To Patient 28 28
No Clinical Signs, Symptoms or Conditions 21 21
Injury 13 13
No Patient Involvement 13 13
Bone Fracture(s) 8 8
Radiation Overdose 7 7
Fall 5 5
Laceration(s) 4 4
Patient Problem/Medical Problem 4 4
Insufficient Information 4 4
Unintended Radiation Exposure 4 4
Electric Shock 3 3
Crushing Injury 3 3
Abrasion 3 3
Bruise/Contusion 2 2
Death 2 2
Contusion 2 2
Tissue Damage 2 2
Head Injury 2 2
Suture Abrasion 2 2
Arthralgia 2 2
No Information 2 2
No Code Available 1 1
Limb Fracture 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Tooth Fracture 1 1
Hematoma 1 1
Hemorrhage, Subdural 1 1
Concussion 1 1
Overdose 1 1
Pain 1 1
Eye Injury 1 1
Radiation Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Healthcare Corp. II Apr-05-2017
2 Agfa N.V. II Sep-25-2018
3 Agfa-Gevaert, N.V. II Jan-07-2019
4 Arcoma AB II Jul-05-2022
5 Carestream Health, Inc. II Jan-13-2020
6 Cuattro LLC II May-08-2020
7 EOS Imaging II Apr-13-2021
8 Fujifilm Medical Systems U.S.A., Inc. II Dec-10-2017
9 GE Healthcare, LLC II Sep-20-2019
10 GE Healthcare, LLC II Jun-10-2019
11 GE Healthcare, LLC II Jul-16-2018
12 NeuroLogica Corporation II Mar-02-2018
13 NeuroLogica Corporation II Aug-25-2017
14 Philips Electronics North America Corporation II Jan-03-2018
15 Philips Electronics North America Corporation II Jun-09-2017
16 Philips Healthcare II Sep-20-2019
17 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
18 Philips Medical Systems DMC GmbH II Jul-12-2022
19 Philips Medical Systems Nederlands II May-03-2018
20 Philips North America, LLC II Apr-28-2020
21 Philips North America, LLC II Mar-23-2019
22 Shanghai United Imaging Healthcare Co., Ltd. II May-12-2022
23 Shanghai United Imaging Healthcare Co., Ltd. II Mar-02-2021
24 Shanghai United Imaging Healthcare Co., Ltd. II Jul-08-2020
25 Shimadzu Medical Systems Usa Com II Jun-29-2017
26 Siemens Medical Solutions USA, Inc II Apr-05-2022
27 Siemens Medical Solutions USA, Inc II Mar-30-2022
28 Siemens Medical Solutions USA, Inc II Apr-02-2021
29 Siemens Medical Solutions USA, Inc II Aug-05-2020
30 Siemens Medical Solutions USA, Inc II May-05-2020
31 Siemens Medical Solutions USA, Inc II Mar-03-2020
32 Siemens Medical Solutions USA, Inc II Feb-20-2020
33 Siemens Medical Solutions USA, Inc II Oct-30-2018
34 Siemens Medical Solutions USA, Inc II Oct-30-2018
35 Swissray Medical II Sep-25-2018
36 Swissray Medical II Sep-18-2018
37 Visaris DOO II May-15-2018
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