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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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CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 2
ARQUILLA, INC. DBA X-CEL X-RAY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 4
CMT MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 2
CUATTRO, LLC
  SUBSTANTIALLY EQUIVALENT 1
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
KONICA MINOLTA HEALTHCARE AMERICAS, INC
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICATECH USA
  SUBSTANTIALLY EQUIVALENT 1
ORICH MEDICAL EQUIPMENT (TIANJIN) 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 1
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RADMEDIX LLC
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
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 3
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SUMMIT INDUSTRIES LLC
  SUBSTANTIALLY EQUIVALENT 2
TELEVERE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISARIS D.O.O. BELGRADE
  SUBSTANTIALLY EQUIVALENT 1
VMI TECNOLOGIAS LTDA
  SUBSTANTIALLY EQUIVALENT 1
XORAN TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 17 17
2017 30 30
2018 36 36
2019 77 77
2020 41 41
2021 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 68 68
Use of Device Problem 39 39
Unintended Movement 17 17
Improper or Incorrect Procedure or Method 15 15
Mechanical Problem 11 11
Detachment of Device or Device Component 9 9
Component Falling 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Unintended System Motion 6 6
Loose or Intermittent Connection 5 5
Device Operates Differently Than Expected 5 5
Problem with Software Installation 4 4
No Display/Image 4 4
Failure to Align 4 4
Detachment Of Device Component 4 4
Computer Software Problem 4 4
Self-Activation or Keying 4 4
Positioning Problem 3 3
Loss of Data 3 3
Device Tipped Over 3 3
Therapeutic or Diagnostic Output Failure 3 3
Installation-Related Problem 3 3
Mechanical Jam 2 2
Off-Label Use 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Break 2 2
Component Missing 2 2
Fire 2 2
Power Problem 2 2
Device Displays Incorrect Message 2 2
Defective Component 2 2
Failure To Adhere Or Bond 2 2
Unintended Collision 2 2
Poor Quality Image 1 1
Thermal Decomposition of Device 1 1
Unintended Power Up 1 1
Arcing 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Energy Output Problem 1 1
Failure to Transmit Record 1 1
Device Remains Activated 1 1
Device Fell 1 1
Incorrect Device Or Component Shipped 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Unintended Ejection 1 1
Migration or Expulsion of Device 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Device Issue 1 1
Structural Problem 1 1
Application Program Problem 1 1
Computer Operating System Problem 1 1
Protective Measures Problem 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Radiation Output Problem 1 1
Misassembled During Installation 1 1
Device Slipped 1 1
Packaging Problem 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 53 53
No Consequences Or Impact To Patient 28 28
No Patient Involvement 15 15
Injury 14 14
No Clinical Signs, Symptoms or Conditions 10 10
Bone Fracture(s) 8 8
Radiation Overdose 7 7
Fall 5 5
Abrasion 4 4
Patient Problem/Medical Problem 4 4
Laceration(s) 3 3
No Information 3 3
Insufficient Information 3 3
Head Injury 2 2
Bruise/Contusion 2 2
Contusion 2 2
Death 2 2
Suture Abrasion 2 2
Electric Shock 2 2
Arthralgia 2 2
Tissue Damage 2 2
Complaint, Ill-Defined 1 1
Tooth Fracture 1 1
Eye Injury 1 1
Hemorrhage, Subdural 1 1
Overdose 1 1
Pain 1 1
No Code Available 1 1
Unspecified Tissue Injury 1 1
Radiation Burn 1 1
Crushing Injury 1 1
Hematoma 1 1
Concussion 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 Carestream Health, Inc. II Jan-13-2020
5 Cuattro LLC II May-08-2020
6 EOS Imaging II Apr-13-2021
7 Fujifilm Medical Systems U.S.A., Inc. II Dec-10-2017
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 NeuroLogica Corporation II Aug-25-2017
13 Philips Electronics North America Corporation II Jan-03-2018
14 Philips Electronics North America Corporation II Jun-09-2017
15 Philips Electronics North America Corporation II Sep-01-2016
16 Philips Electronics North America Corporation II Feb-05-2016
17 Philips Healthcare II Sep-20-2019
18 Philips Healthcare II Jun-03-2016
19 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
20 Philips Medical Systems Nederlands II May-03-2018
21 Philips Medical Systems, Inc. II Mar-31-2016
22 Philips North America, LLC II Apr-28-2020
23 Philips North America, LLC II Mar-23-2019
24 Shanghai United Imaging Healthcare Co., Ltd. II Mar-02-2021
25 Shanghai United Imaging Healthcare Co., Ltd. II Jul-08-2020
26 Shimadzu Medical Systems Usa Com II Jun-29-2017
27 Siemens Medical Solutions USA, Inc II Apr-02-2021
28 Siemens Medical Solutions USA, Inc II Aug-05-2020
29 Siemens Medical Solutions USA, Inc II May-05-2020
30 Siemens Medical Solutions USA, Inc II Mar-03-2020
31 Siemens Medical Solutions USA, Inc II Feb-20-2020
32 Siemens Medical Solutions USA, Inc II Oct-30-2018
33 Siemens Medical Solutions USA, Inc II Oct-30-2018
34 Siemens Medical Solutions USA, Inc II Oct-04-2016
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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