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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
CANON MEDICAL SYSTEMS CORPORATION
  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 5
RADIOLOGY INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 36 36
2018 36 36
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 41 41
Use of Device Problem 36 36
Unintended Movement 25 25
Detachment of Device or Device Component 13 13
Device Operates Differently Than Expected 13 13
No Display/Image 11 11
Mechanical Problem 11 11
Poor Quality Image 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Device Fell 8 8
Display or Visual Feedback Problem 8 8
Unintended System Motion 8 8
Break 7 7
Insufficient Information 7 7
Output Problem 7 7
Therapeutic or Diagnostic Output Failure 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Unintended Collision 5 5
Device Displays Incorrect Message 5 5
Device Dislodged or Dislocated 5 5
Detachment Of Device Component 4 4
Device Handling Problem 4 4
Unexpected Shutdown 3 3
Device Alarm System 3 3
No Device Output 3 3
Failure to Power Up 3 3
Defective Device 3 3
Communication or Transmission Problem 3 3
Defective Component 3 3
Improper or Incorrect Procedure or Method 3 3
Smoking 2 2
Difficult or Delayed Activation 2 2
Malposition of Device 2 2
Unstable 2 2
Improper Device Output 2 2
Inappropriate or Unexpected Reset 2 2
Installation-Related Problem 2 2
Product Quality Problem 2 2
Overheating of Device 2 2
Fire 2 2
Image Display Error/Artifact 2 2
Image Orientation Incorrect 2 2
Patient Data Problem 2 2
Radiation Output Failure 2 2
Activation Problem 2 2
Radiation Overexposure 2 2
Positioning Problem 2 2
Power Problem 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Mechanics Altered 1 1
Protective Measures Problem 1 1
Operating System Becomes Nonfunctional 1 1
Appropriate Term/Code Not Available 1 1
No Apparent Adverse Event 1 1
Misassembled During Installation 1 1
Intermittent Communication Failure 1 1
Intermittent Energy Output 1 1
Radiation Output 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
Imprecision 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Application Program Problem: Dose Calculation Error 1 1
Electrical /Electronic Property Problem 1 1
Entrapment of Device 1 1
Component Falling 1 1
Computer Software Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Insufficient Cooling 1 1
Crack 1 1
Display Difficult to Read 1 1
Erratic or Intermittent Display 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Misassembled 1 1
Moisture Damage 1 1
Device Emits Odor 1 1
Difficult To Position 1 1
Loss of Power 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Rupture 1 1
Inadequate Service 1 1
Device Slipped 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
Human Factors Issue 1 1
Device Sensing Problem 1 1
Difficult to Open or Close 1 1
Computer Operating System Problem 1 1
Connection Problem 1 1
Data Back-Up Problem 1 1
Loss of Data 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 61 61
No Consequences Or Impact To Patient 26 26
Radiation Exposure, Unintended 24 24
Insufficient Information 14 14
No Information 10 10
No Patient Involvement 10 10
Injury 8 8
Fall 6 6
Pain 6 6
Bone Fracture(s) 4 4
Laceration(s) 4 4
No Code Available 4 4
Patient Problem/Medical Problem 3 3
Suture Abrasion 3 3
Full thickness (Third Degree) Burn 2 2
Complaint, Ill-Defined 2 2
Unintended Radiation Exposure 2 2
Muscle/Tendon Damage 1 1
Vascular Dissection 1 1
Device Embedded In Tissue or Plaque 1 1
Abdominal Cramps 1 1
Nausea 1 1
Overdose 1 1
Stenosis 1 1
Discomfort 1 1
Arthralgia 1 1
Sore Throat 1 1
Sweating 1 1
Post Operative Wound Infection 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
Exsanguination 1 1
Paralysis 1 1
Pneumothorax 1 1
Seroma 1 1
Sprain 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Tissue Damage 1 1
Perforation of Vessels 1 1
Vomiting 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 Hans Pausch Rontgengeratebau Gmbh II May-30-2017
6 PHILIPS MEDICAL SYSTEMS II Feb-14-2024
7 Philips Electronics North America Corporation II Jan-10-2018
8 Philips Healthcare II Nov-24-2021
9 Philips Medical Systems DMC GmbH II Jul-12-2022
10 Philips Medical Systems Gmbh, DMC II Aug-28-2021
11 Philips Medical Systems Gmbh, DMC II Feb-20-2020
12 Philips Medical Systems Gmbh, DMC II Feb-12-2019
13 Philips Medical Systems Nederlands II Jun-27-2018
14 Philips North America, LLC II Jul-10-2020
15 Philips North America, LLC II Jun-03-2020
16 Philips North America, LLC II Apr-24-2020
17 Philips North America, LLC II Apr-11-2019
18 Philips North America, LLC II Mar-23-2019
19 Philips North America II Feb-09-2024
20 Philips North America II May-15-2023
21 Philips North America Llc II Nov-08-2023
22 Philips North America Llc II Apr-10-2023
23 Philips North America Llc II Nov-09-2021
24 Shimadzu Medical Systems II Apr-07-2022
25 Siemens Medical Solutions USA, Inc II Jan-20-2023
26 Siemens Medical Solutions USA, Inc II Oct-21-2022
27 Siemens Medical Solutions USA, Inc II Jun-27-2022
28 Siemens Medical Solutions USA, Inc II Jan-08-2021
29 Siemens Medical Solutions USA, Inc II Aug-05-2020
30 Siemens Medical Solutions USA, Inc II Mar-07-2019
31 Siemens Medical Solutions USA, Inc II Jul-20-2018
32 Siemens Medical Solutions USA, Inc II Mar-20-2018
33 Toshiba American Medical Systems Inc II Mar-02-2018
34 Toshiba American Medical Systems Inc II Oct-17-2017
35 Toshiba American Medical Systems Inc II Mar-14-2017
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