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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 3
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
VAREX IMAGING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 39 39
2021 35 35
2022 34 36
2023 41 41
2024 25 25
2025 33 33
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 42 42
Detachment of Device or Device Component 23 23
Unintended Movement 16 16
Use of Device Problem 15 15
Mechanical Problem 10 10
Device Fell 9 9
Display or Visual Feedback Problem 7 7
Break 7 7
No Display/Image 7 7
Device Handling Problem 7 7
Radiation Output Failure 7 7
Unintended Collision 6 6
Unintended System Motion 6 6
Application Program Freezes, Becomes Nonfunctional 5 5
Output Problem 5 5
Unexpected Shutdown 3 3
Device Dislodged or Dislocated 3 3
Poor Quality Image 3 3
Insufficient Information 3 3
Mechanical Jam 2 2
Electrical /Electronic Property Problem 2 2
Inappropriate or Unexpected Reset 2 2
Activation Failure 2 2
Product Quality Problem 2 2
Computer Operating System Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Twisted/Bent 2 2
Difficult or Delayed Activation 2 2
Patient Device Interaction Problem 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 3
Activation Problem 2 2
No Device Output 1 1
Device Slipped 1 1
Fluid/Blood Leak 1 1
Unstable 1 1
Loss of Data 1 1
Deformation Due to Compressive Stress 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of Power 1 1
Device-Device Incompatibility 1 1
Operating System Becomes Nonfunctional 1 1
Material Split, Cut or Torn 1 1
Insufficient Cooling 1 1
Connection Problem 1 1
Radiation Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 126 128
Insufficient Information 15 15
Radiation Exposure, Unintended 12 12
No Known Impact Or Consequence To Patient 9 9
No Consequences Or Impact To Patient 7 7
Pain 4 4
No Patient Involvement 3 3
Laceration(s) 3 3
Injury 2 2
Muscle/Tendon Damage 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
Dizziness 1 1
Vascular Dissection 1 1
Exsanguination 1 1
Bone Fracture(s) 1 1
Contusion 1 1
Paralysis 1 1
Needle Stick/Puncture 1 1
Discomfort 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 Nov-07-2025
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 North America, LLC II Jul-10-2020
11 Philips North America, LLC II Jun-03-2020
12 Philips North America, LLC II Apr-24-2020
13 Philips North America II Dec-09-2025
14 Philips North America II Feb-09-2024
15 Philips North America II May-15-2023
16 Philips North America Llc II Nov-08-2023
17 Philips North America Llc II Apr-10-2023
18 Philips North America Llc II Nov-09-2021
19 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION II Nov-07-2024
20 Shimadzu Medical Systems II Apr-07-2022
21 Siemens Medical Solutions USA, Inc II Jun-17-2025
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
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