Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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, fluoroscopic, image-intensified
Product CodeJAA
Regulation Number 892.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
AGFA HEALTHCARE N.V.
  SUBSTANTIALLY EQUIVALENT 1
AGFA N.V.
  SUBSTANTIALLY EQUIVALENT 1
APELEM-DMS GROUP
  SUBSTANTIALLY EQUIVALENT 3
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CMT MEDICAL TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
CMT MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
GEMSS MEDICAL SYSTEMS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
GENERAL MEDICAL MERATE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
GENERAL MEDICAL MERATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
IMAGING ENGINEERING, LLC
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 4
PAUSCH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 5
RADIOLOGY INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 2
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
STEPHANIX RADIOLOGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED
  SUBSTANTIALLY EQUIVALENT 1
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 10265 10265
2015 2922 2922
2016 33 33
2017 36 36
2018 36 36
2019 49 49
2020 39 39
2021 35 35
2022 34 34
2023 41 41
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Operating System Problem 3428 3428
Device Displays Incorrect Message 3299 3299
Device Inoperable 1405 1405
No Display/Image 1381 1381
Failure to Power Up 1204 1204
Device Operates Differently Than Expected 1188 1188
Device Stops Intermittently 875 875
No Device Output 790 790
Loss of Power 740 740
Application Interface Becomes Non-Functional Or Program Exits Abnormally 680 680
Loss of Data 262 262
Poor Quality Image 237 237
Communication or Transmission Problem 204 204
Image Display Error/Artifact 186 186
Patient Data Problem 161 161
Self-Activation or Keying 149 149
Data Problem 128 128
Mechanical Problem 104 104
Break 97 97
Intermittent Continuity 76 76
Failure to Back-Up 68 68
Output Problem 63 63
Difficult or Delayed Activation 59 59
Noise, Audible 56 56
Arcing 54 54
Sticking 51 51
Mechanical Jam 48 48
Device Operational Issue 46 46
Mechanics Altered 44 44
Use of Device Problem 39 39
Connection Problem 37 37
Unintended Movement 35 35
Data Back-Up Problem 32 32
Reset Problem 31 31
Detachment Of Device Component 30 30
Loose or Intermittent Connection 29 29
Operating System Becomes Nonfunctional 29 29
Detachment of Device or Device Component 27 27
Improper Device Output 26 26
Failure to Shut Off 25 25
Display or Visual Feedback Problem 25 25
Power Problem 25 25
Computer Software Problem 21 21
Unstable 21 21
Radiation Overexposure 20 20
Electrical /Electronic Property Problem 19 19
Degraded 18 18
Component Falling 17 17
Overheating of Device 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Charging Problem 14 14
Positioning Problem 13 13
Inappropriate or Unexpected Reset 12 12
Unintended System Motion 12 12
Device Alarm System 12 12
Erratic or Intermittent Display 12 12
Difficult to Remove 11 11
Disconnection 10 10
Application Program Problem 10 10
Defective Component 10 10
Unintended Collision 9 9
Battery Problem 8 8
Device Dislodged or Dislocated 8 8
Insufficient Information 8 8
Device Fell 7 7
Difficult to Open or Close 7 7
Crack 7 7
Image Orientation Incorrect 6 6
Failure to Sense 6 6
Delivery System Failure 6 6
Improper or Incorrect Procedure or Method 6 6
Device Slipped 6 6
Defective Device 6 6
Appropriate Term/Code Not Available 6 6
Therapeutic or Diagnostic Output Failure 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Failure to Reset 5 5
Device Emits Odor 5 5
Image Reversal 5 5
Material Too Rigid or Stiff 4 4
Failure to Charge 4 4
Blocked Connection 4 4
Material Integrity Problem 4 4
Material Protrusion/Extrusion 3 3
Protective Measures Problem 3 3
Device Handling Problem 3 3
Unexpected Shutdown 3 3
Electrical Shorting 3 3
Device Sensing Problem 3 3
Component Missing 3 3
Failure to Align 3 3
Smoking 3 3
Failure to Read Input Signal 3 3
Signal Artifact/Noise 3 3
Product Quality Problem 3 3
Fire 3 3
Fluid/Blood Leak 2 2
Leak/Splash 2 2
Nonstandard Device 2 2
Device Remains Activated 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 11123 11123
No Consequences Or Impact To Patient 2094 2094
No Information 635 635
No Clinical Signs, Symptoms or Conditions 81 81
Radiation Exposure, Unintended 44 44
No Patient Involvement 34 34
Fall 15 15
Injury 13 13
Insufficient Information 13 13
Pain 12 12
Bone Fracture(s) 8 8
No Code Available 7 7
Laceration(s) 6 6
Radiation Overdose 6 6
Headache 3 3
Patient Problem/Medical Problem 3 3
Suture Abrasion 3 3
Physical Entrapment 2 2
Full thickness (Third Degree) Burn 2 2
Complaint, Ill-Defined 2 2
Unintended Radiation Exposure 2 2
Tissue Damage 2 2
Head Injury 2 2
Uremia 2 2
Abrasion 2 2
Bruise/Contusion 2 2
Burn(s) 2 2
Death 2 2
Exsanguination 1 1
Fever 1 1
Contusion 1 1
Achalasia 1 1
Paralysis 1 1
Pneumothorax 1 1
Seizures 1 1
Seroma 1 1
Sprain 1 1
Therapeutic Effects, Unexpected 1 1
Thrombosis 1 1
Thrombus 1 1
Stenosis 1 1
Arthralgia 1 1
Sore Throat 1 1
Sweating 1 1
Post Operative Wound Infection 1 1
Low Oxygen Saturation 1 1
Perforation of Vessels 1 1
Vomiting 1 1
Nausea 1 1
Overdose 1 1
Hemorrhage/Bleeding 1 1
Hair Loss 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
Pregnancy 1 1
Muscle/Tendon Damage 1 1
Vascular Dissection 1 1
Anxiety 1 1
Discomfort 1 1
Abdominal Cramps 1 1
Drainage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agfa N.V. II Jun-03-2020
2 Agfa N.V. II Jul-30-2019
3 GE Healthcare II Jul-20-2015
4 GE Healthcare II Jul-02-2015
5 GE Healthcare, LLC II Feb-09-2021
6 GE Healthcare, LLC II Jun-10-2019
7 GE Healthcare, LLC II Dec-23-2016
8 GE Healthcare, LLC II Oct-02-2014
9 GE Healthcare, LLC II Jan-21-2014
10 GE Healthcare, LLC II Oct-17-2013
11 GE Healthcare, LLC II Aug-20-2013
12 GE Healthcare, LLC II May-06-2011
13 GE Medical Systems, LLC II Nov-09-2009
14 GE OEC Medical Systems, Inc II Aug-22-2012
15 GE OEC Medical Systems, Inc II Aug-17-2012
16 GE OEC Medical Systems, Inc II Aug-01-2012
17 GE OEC Medical Systems, Inc I Jul-24-2012
18 GE OEC Medical Systems, Inc II Jul-18-2012
19 GE OEC Medical Systems, Inc II Jun-22-2012
20 Ge Healthcare II Jan-20-2010
21 Ge Healthcare II Sep-24-2009
22 Hans Pausch Rontgengeratebau Gmbh II May-30-2017
23 Hologic, Inc. II May-17-2013
24 Hologic, Inc. II Sep-25-2012
25 Hologic, Inc. II Aug-12-2011
26 NRT - Nordisk Rontgen Teknik A/S II Sep-29-2009
27 OEC Medical Systems, Inc II Jan-05-2009
28 PHILIPS MEDICAL SYSTEMS II Feb-14-2024
29 Philips Electronics North America Corporation II Jan-10-2018
30 Philips Healthcare II Nov-24-2021
31 Philips Healthcare Inc. II Mar-16-2012
32 Philips Healthcare Inc. II Oct-27-2011
33 Philips Healthcare Inc. II Jul-08-2011
34 Philips Medical Systems DMC GmbH II Jul-12-2022
35 Philips Medical Systems Gmbh, DMC II Aug-28-2021
36 Philips Medical Systems Gmbh, DMC II Feb-20-2020
37 Philips Medical Systems Gmbh, DMC II Feb-12-2019
38 Philips Medical Systems Gmbh, DMC II Mar-23-2012
39 Philips Medical Systems Nederlands II Jun-27-2018
40 Philips Medical Systems North America Co. Phillips II Oct-25-2010
41 Philips Medical Systems North America Co. Phillips II Sep-22-2010
42 Philips Medical Systems North America Co. Phillips II Sep-24-2009
43 Philips Medical Systems North America Co. Phillips II Sep-24-2009
44 Philips Medical Systems North America Co. Phillips II Jan-26-2009
45 Philips North America, LLC II Jul-10-2020
46 Philips North America, LLC II Jun-03-2020
47 Philips North America, LLC II Apr-24-2020
48 Philips North America, LLC II Apr-11-2019
49 Philips North America, LLC II Mar-23-2019
50 Philips North America II Feb-09-2024
51 Philips North America II May-15-2023
52 Philips North America Llc II Nov-08-2023
53 Philips North America Llc II Apr-10-2023
54 Philips North America Llc II Nov-09-2021
55 Shimadzu Medical Systems II Apr-07-2022
56 Shimadzu Medical Systems II Dec-23-2016
57 Shimadzu Medical Systems II Nov-09-2015
58 Siemens Medical Solutions USA, Inc II Jan-20-2023
59 Siemens Medical Solutions USA, Inc II Oct-21-2022
60 Siemens Medical Solutions USA, Inc II Jun-27-2022
61 Siemens Medical Solutions USA, Inc II Jan-08-2021
62 Siemens Medical Solutions USA, Inc II Aug-05-2020
63 Siemens Medical Solutions USA, Inc II Mar-07-2019
64 Siemens Medical Solutions USA, Inc II Jul-20-2018
65 Siemens Medical Solutions USA, Inc II Mar-20-2018
66 Siemens Medical Solutions USA, Inc II Mar-31-2016
67 Siemens Medical Solutions USA, Inc II May-23-2015
68 Siemens Medical Solutions USA, Inc II Sep-10-2014
69 Siemens Medical Solutions USA, Inc II Nov-27-2013
70 Siemens Medical Solutions USA, Inc II Apr-11-2013
71 Siemens Medical Solutions USA, Inc II Sep-10-2012
72 Siemens Medical Solutions USA, Inc II Jan-27-2012
73 Siemens Medical Solutions USA, Inc II Mar-27-2010
74 Siemens Medical Solutions USA, Inc II Nov-12-2009
75 Siemens Medical Solutions USA, Inc II Jun-16-2009
76 Siemens Medical Solutions USA, Inc II May-06-2009
77 Toshiba American Medical Systems Inc II Mar-02-2018
78 Toshiba American Medical Systems Inc II Oct-17-2017
79 Toshiba American Medical Systems Inc II Mar-14-2017
80 Toshiba American Medical Systems Inc II Mar-21-2016
81 Toshiba American Medical Systems Inc II Jul-10-2013
82 Toshiba American Medical Systems Inc II Apr-15-2011
83 Ziehm Imaging Inc II Aug-25-2016
84 Ziehm Imaging Inc II Apr-16-2012
-
-