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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
Regulation Description Image-intensified fluoroscopic x-ray system.
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
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
IMAGING ENGINEERING, LLC
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NRT X-RAY A/S
  SUBSTANTIALLY EQUIVALENT 1
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 4
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 39 39
2021 35 35
2022 34 34
2023 41 41
2024 25 25
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 36 36
Detachment of Device or Device Component 18 18
Use of Device Problem 15 15
Unintended Movement 15 15
Mechanical Problem 10 10
Display or Visual Feedback Problem 7 7
Device Fell 7 7
Unintended System Motion 6 6
Unintended Collision 5 5
Break 5 5
Output Problem 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Device Handling Problem 4 4
No Display/Image 4 4
Unexpected Shutdown 3 3
Device Dislodged or Dislocated 3 3
Poor Quality Image 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Material Twisted/Bent 2 2
Difficult or Delayed Activation 2 2
Product Quality Problem 2 2
Radiation Output Failure 2 2
Patient Data Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Integrity Problem 2 2
Defective Device 2 2
Defective Component 2 2
Smoking 2 2
Insufficient Information 2 2
Inappropriate or Unexpected Reset 2 2
Activation Problem 2 2
Electrical /Electronic Property Problem 2 2
Connection Problem 1 1
Protective Measures Problem 1 1
Insufficient Cooling 1 1
Power Problem 1 1
Activation Failure 1 1
Installation-Related Problem 1 1
Device Sensing Problem 1 1
Loss of Power 1 1
Improper or Incorrect Procedure or Method 1 1
Deformation Due to Compressive Stress 1 1
Loss of Data 1 1
Mechanical Jam 1 1
Fluid/Blood Leak 1 1
Material Deformation 1 1
No Device Output 1 1
Computer Operating System Problem 1 1
Misassembled 1 1
Use of Incorrect Control/Treatment Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 106 106
Insufficient Information 14 14
Radiation Exposure, Unintended 12 12
No Known Impact Or Consequence To Patient 9 9
No Consequences Or Impact To Patient 7 7
No Patient Involvement 3 3
Pain 3 3
Injury 2 2
Laceration(s) 2 2
Full thickness (Third Degree) Burn 2 2
Unintended Radiation Exposure 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arthralgia 1 1
No Code Available 1 1
Vascular Dissection 1 1
Exsanguination 1 1
Contusion 1 1
Paralysis 1 1
Discomfort 1 1
Muscle/Tendon Damage 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Sore Throat 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agfa N.V. II Aug-27-2024
2 Agfa N.V. II Jun-03-2020
3 GE Healthcare, LLC II Feb-09-2021
4 PHILIPS MEDICAL SYSTEMS II Feb-14-2024
5 Philips Healthcare II Nov-24-2021
6 Philips Medical Systems DMC GmbH II Jul-12-2022
7 Philips Medical Systems Gmbh, DMC II Aug-28-2021
8 Philips Medical Systems Gmbh, DMC II Feb-20-2020
9 Philips North America, LLC II Jul-10-2020
10 Philips North America, LLC II Jun-03-2020
11 Philips North America, LLC II Apr-24-2020
12 Philips North America II Feb-09-2024
13 Philips North America II May-15-2023
14 Philips North America Llc II Nov-08-2023
15 Philips North America Llc II Apr-10-2023
16 Philips North America Llc II Nov-09-2021
17 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION II Nov-07-2024
18 Shimadzu Medical Systems II Apr-07-2022
19 Siemens Medical Solutions USA, Inc II Jun-17-2025
20 Siemens Medical Solutions USA, Inc II Jan-20-2023
21 Siemens Medical Solutions USA, Inc II Oct-21-2022
22 Siemens Medical Solutions USA, Inc II Jun-27-2022
23 Siemens Medical Solutions USA, Inc II Jan-08-2021
24 Siemens Medical Solutions USA, Inc II Aug-05-2020
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