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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, 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 1
CMT MEDICAL TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA, INC
  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 3
PAUSCH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 2
RADIOLOGY INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 36 36
2019 49 49
2020 39 39
2021 35 35
2022 34 34
2023 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 34 34
Use of Device Problem 28 28
Unintended Movement 19 19
Detachment of Device or Device Component 11 11
Mechanical Problem 11 11
Poor Quality Image 9 9
No Display/Image 9 9
Display or Visual Feedback Problem 7 7
Unintended System Motion 7 7
Output Problem 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Break 6 6
Unintended Collision 5 5
Device Dislodged or Dislocated 5 5
Therapeutic or Diagnostic Output Failure 5 5
Device Fell 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Insufficient Information 4 4
Device Displays Incorrect Message 4 4
Defective Component 3 3
Device Operates Differently Than Expected 3 3
Defective Device 3 3
Device Alarm System 3 3
No Device Output 3 3
Failure to Power Up 3 3
Detachment Of Device Component 3 3
Product Quality Problem 2 2
Image Orientation Incorrect 2 2
Difficult or Delayed Activation 2 2
Inappropriate or Unexpected Reset 2 2
Installation-Related Problem 2 2
Material Integrity Problem 2 2
Smoking 2 2
Unstable 2 2
Improper or Incorrect Procedure or Method 2 2
Malposition of Device 2 2
Communication or Transmission Problem 2 2
Activation Problem 2 2
Radiation Output Failure 2 2
Unexpected Shutdown 2 2
Patient Data Problem 2 2
Radiation Overexposure 2 2
Positioning Problem 2 2
Power Problem 1 1
Operating System Becomes Nonfunctional 1 1
No Apparent Adverse Event 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Intermittent Energy Output 1 1
Radiation Output Problem 1 1
Misassembled During Installation 1 1
Appropriate Term/Code Not Available 1 1
Intermittent Communication Failure 1 1
Computer Operating System Problem 1 1
Connection Problem 1 1
Data Back-Up Problem 1 1
Loss of Data 1 1
Patient-Device Incompatibility 1 1
Application Program Version or Upgrade Problem 1 1
Material Perforation 1 1
Visual Prompts will not Clear 1 1
High Sensing Threshold 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 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
Misassembled 1 1
Device Emits Odor 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Rupture 1 1
Inadequate Service 1 1
Device Slipped 1 1
Overheating of Device 1 1
Loss of Power 1 1
Output above Specifications 1 1
Component Falling 1 1
Computer Software Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Crack 1 1
Display Difficult to Read 1 1
Erratic or Intermittent Display 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 64 64
No Known Impact Or Consequence To Patient 41 41
No Consequences Or Impact To Patient 23 23
Radiation Exposure, Unintended 20 20
Insufficient Information 11 11
No Patient Involvement 10 10
No Information 7 7
Pain 6 6
Fall 5 5
Injury 5 5
Patient Problem/Medical Problem 3 3
Suture Abrasion 2 2
No Code Available 2 2
Unintended Radiation Exposure 2 2
Bone Fracture(s) 2 2
Laceration(s) 2 2
Overdose 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Seroma 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Tissue Damage 1 1
Perforation of Vessels 1 1
Hair Loss 1 1
Headache 1 1
Fever 1 1
Radiation Overdose 1 1
Abrasion 1 1
Bruise/Contusion 1 1
Contusion 1 1
Death 1 1
Muscle/Tendon Damage 1 1
Abdominal Cramps 1 1
Sweating 1 1
Post Operative Wound Infection 1 1
Device Embedded In Tissue or Plaque 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 Electronics North America Corporation II Jan-10-2018
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 Medical Systems Nederlands II Jun-27-2018
12 Philips North America, LLC II Jul-10-2020
13 Philips North America, LLC II Jun-03-2020
14 Philips North America, LLC II Apr-24-2020
15 Philips North America, LLC II Apr-11-2019
16 Philips North America, LLC II Mar-23-2019
17 Philips North America II May-15-2023
18 Philips North America Llc II Apr-10-2023
19 Philips North America Llc II Nov-09-2021
20 Shimadzu Medical Systems II Apr-07-2022
21 Siemens Medical Solutions USA, Inc II Jan-20-2023
22 Siemens Medical Solutions USA, Inc II Oct-21-2022
23 Siemens Medical Solutions USA, Inc II Jun-27-2022
24 Siemens Medical Solutions USA, Inc II Jan-08-2021
25 Siemens Medical Solutions USA, Inc II Aug-05-2020
26 Siemens Medical Solutions USA, Inc II Mar-07-2019
27 Siemens Medical Solutions USA, Inc II Jul-20-2018
28 Siemens Medical Solutions USA, Inc II Mar-20-2018
29 Toshiba American Medical Systems Inc II Mar-02-2018
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