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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 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

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 35 35
Use of Device Problem 15 15
Detachment of Device or Device Component 14 14
Unintended Movement 14 14
Mechanical Problem 9 9
Device Fell 7 7
Display or Visual Feedback Problem 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
Unintended System Motion 4 4
Unexpected Shutdown 3 3
Poor Quality Image 3 3
Device Dislodged or Dislocated 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
Inappropriate or Unexpected Reset 2 2
Activation Problem 2 2
Power Problem 1 1
Protective Measures Problem 1 1
Activation Failure 1 1
Installation-Related Problem 1 1
Connection Problem 1 1
Device Sensing Problem 1 1
Electrical /Electronic Property Problem 1 1
Loss of Power 1 1
Improper or Incorrect Procedure or Method 1 1
Material Deformation 1 1
Computer Operating System Problem 1 1
Deformation Due to Compressive Stress 1 1
Misassembled 1 1
Loss of Data 1 1
Use of Incorrect Control/Treatment Settings 1 1
Fluid/Blood Leak 1 1
No Device Output 1 1
Mechanics Altered 1 1
Flare or Flash 1 1
Component Missing 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 93 93
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
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 Jan-20-2023
20 Siemens Medical Solutions USA, Inc II Oct-21-2022
21 Siemens Medical Solutions USA, Inc II Jun-27-2022
22 Siemens Medical Solutions USA, Inc II Jan-08-2021
23 Siemens Medical Solutions USA, Inc II Aug-05-2020
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