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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, fluoroscopic, image-intensified
Product CodeJAA
Regulation Number 892.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
AGFA N.V.
  SUBSTANTIALLY EQUIVALENT 1
APELEM-DMS GROUP
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CMT MEDICAL TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
IMAGING ENGINEERING, LLC
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 4
RADIOLOGY INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 49 49
2020 39 39
2021 35 35
2022 34 34
2023 41 41
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 34 34
Use of Device Problem 26 26
Unintended Movement 20 20
Mechanical Problem 11 11
Detachment of Device or Device Component 10 10
No Display/Image 9 9
Display or Visual Feedback Problem 8 8
Poor Quality Image 8 8
Unintended System Motion 7 7
Output Problem 6 6
Device Fell 6 6
Application Program Freezes, Becomes Nonfunctional 5 5
Therapeutic or Diagnostic Output Failure 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Device Dislodged or Dislocated 5 5
Unintended Collision 5 5
Break 5 5
Device Handling Problem 4 4
Unexpected Shutdown 3 3
Defective Component 3 3
Smoking 2 2
Improper or Incorrect Procedure or Method 2 2
Device Alarm System 2 2
No Device Output 2 2
Failure to Power Up 2 2
Product Quality Problem 2 2
Image Orientation Incorrect 2 2
Inappropriate or Unexpected Reset 2 2
Difficult or Delayed Activation 2 2
Defective Device 2 2
Malposition of Device 2 2
Communication or Transmission Problem 2 2
Insufficient Information 2 2
Positioning Problem 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Patient Data Problem 2 2
Radiation Output Failure 2 2
Activation Problem 2 2
Misassembled During Installation 1 1
Intermittent Communication Failure 1 1
Intermittent Energy Output 1 1
Radiation Output Problem 1 1
Activation Failure 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Mechanics Altered 1 1
Material Protrusion/Extrusion 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Radiation Overexposure 1 1
Appropriate Term/Code Not Available 1 1
No Apparent Adverse Event 1 1
Operating System Becomes Nonfunctional 1 1
Computer Operating System Problem 1 1
Connection Problem 1 1
Data Back-Up Problem 1 1
Loss of Data 1 1
Application Program Version or Upgrade Problem 1 1
Deformation Due to Compressive Stress 1 1
Device Displays Incorrect Message 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Flare or Flash 1 1
Device Sensing Problem 1 1
Imprecision 1 1
Loose or Intermittent Connection 1 1
Use of Incorrect Control/Treatment Settings 1 1
Display Difficult to Read 1 1
Device Emits Odor 1 1
Misassembled 1 1
Moisture Damage 1 1
Application Program Problem: Dose Calculation Error 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Image Display Error/Artifact 1 1
Device Slipped 1 1
Overheating of Device 1 1
Loss of Power 1 1
Energy Output Problem 1 1
Material Perforation 1 1
Visual Prompts will not Clear 1 1
Unstable 1 1
High Sensing Threshold 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 82 82
No Known Impact Or Consequence To Patient 28 28
No Consequences Or Impact To Patient 17 17
Radiation Exposure, Unintended 15 15
Insufficient Information 14 14
No Patient Involvement 7 7
No Information 4 4
Patient Problem/Medical Problem 3 3
Injury 3 3
Pain 3 3
Laceration(s) 2 2
Full thickness (Third Degree) Burn 2 2
No Code Available 2 2
Unintended Radiation Exposure 2 2
Muscle/Tendon Damage 1 1
Vascular Dissection 1 1
Overdose 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Arthralgia 1 1
Sore Throat 1 1
Post Operative Wound Infection 1 1
Suture Abrasion 1 1
Paralysis 1 1
Seroma 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Tissue Damage 1 1
Perforation of Vessels 1 1
Abrasion 1 1
Bruise/Contusion 1 1
Contusion 1 1
Death 1 1
Exsanguination 1 1
Fall 1 1
Bone Fracture(s) 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, LLC II Feb-09-2021
4 GE Healthcare, LLC II Jun-10-2019
5 PHILIPS MEDICAL SYSTEMS II Feb-14-2024
6 Philips Healthcare II Nov-24-2021
7 Philips Medical Systems DMC GmbH II Jul-12-2022
8 Philips Medical Systems Gmbh, DMC II Aug-28-2021
9 Philips Medical Systems Gmbh, DMC II Feb-20-2020
10 Philips Medical Systems Gmbh, DMC II Feb-12-2019
11 Philips North America, LLC II Jul-10-2020
12 Philips North America, LLC II Jun-03-2020
13 Philips North America, LLC II Apr-24-2020
14 Philips North America, LLC II Apr-11-2019
15 Philips North America, LLC II Mar-23-2019
16 Philips North America II Feb-09-2024
17 Philips North America II May-15-2023
18 Philips North America Llc II Nov-08-2023
19 Philips North America Llc II Apr-10-2023
20 Philips North America Llc II Nov-09-2021
21 Shimadzu Medical Systems II Apr-07-2022
22 Siemens Medical Solutions USA, Inc II Jan-20-2023
23 Siemens Medical Solutions USA, Inc II Oct-21-2022
24 Siemens Medical Solutions USA, Inc II Jun-27-2022
25 Siemens Medical Solutions USA, Inc II Jan-08-2021
26 Siemens Medical Solutions USA, Inc II Aug-05-2020
27 Siemens Medical Solutions USA, Inc II Mar-07-2019
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