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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 3
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 4
RADIOLOGY INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 49 49
2020 39 39
2021 35 35
2022 34 34
2023 41 41
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 35 35
Use of Device Problem 29 29
Unintended Movement 20 20
Detachment of Device or Device Component 12 12
Mechanical Problem 11 11
No Display/Image 9 9
Display or Visual Feedback Problem 8 8
Poor Quality Image 8 8
Unintended System Motion 7 7
Device Fell 7 7
Output Problem 6 6
Therapeutic or Diagnostic Output Failure 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Device Dislodged or Dislocated 5 5
Unintended Collision 5 5
Break 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Device Handling Problem 4 4
Unexpected Shutdown 3 3
Defective Component 3 3
Smoking 2 2
Improper or Incorrect Procedure or Method 2 2
Device Alarm System 2 2
No Device Output 2 2
Failure to Power Up 2 2
Product Quality Problem 2 2
Image Orientation Incorrect 2 2
Inappropriate or Unexpected Reset 2 2
Difficult or Delayed Activation 2 2
Defective Device 2 2
Malposition of Device 2 2
Communication or Transmission Problem 2 2
Insufficient Information 2 2
Positioning Problem 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Patient Data Problem 2 2
Radiation Output Failure 2 2
Activation Problem 2 2
Misassembled During Installation 1 1
Intermittent Communication Failure 1 1
Intermittent Energy Output 1 1
Radiation Output Problem 1 1
Activation Failure 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Mechanics Altered 1 1
Material Protrusion/Extrusion 1 1
Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 86 86
No Known Impact Or Consequence To Patient 28 28
No Consequences Or Impact To Patient 17 17
Radiation Exposure, Unintended 15 15
Insufficient Information 14 14
No Patient Involvement 7 7
No Information 4 4
Pain 4 4
Patient Problem/Medical Problem 3 3
Injury 3 3
Laceration(s) 3 3
No Code Available 2 2
Full thickness (Third Degree) Burn 2 2
Unintended Radiation Exposure 2 2
Death 1 1
Complaint, Ill-Defined 1 1
Arthralgia 1 1
Vascular Dissection 1 1
Exsanguination 1 1
Bone Fracture(s) 1 1
Abrasion 1 1
Suture Abrasion 1 1
Contusion 1 1
Overdose 1 1
Post Operative Wound Infection 1 1
Paralysis 1 1
Seroma 1 1
Discomfort 1 1
Fall 1 1
Muscle/Tendon Damage 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Tissue Damage 1 1
Therapeutic Effects, Unexpected 1 1
Sore Throat 1 1
Thrombus 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 Agfa N.V. II Jul-30-2019
4 GE Healthcare, LLC II Feb-09-2021
5 GE Healthcare, LLC II Jun-10-2019
6 PHILIPS MEDICAL SYSTEMS II Feb-14-2024
7 Philips Healthcare II Nov-24-2021
8 Philips Medical Systems DMC GmbH II Jul-12-2022
9 Philips Medical Systems Gmbh, DMC II Aug-28-2021
10 Philips Medical Systems Gmbh, DMC II Feb-20-2020
11 Philips Medical Systems Gmbh, DMC II Feb-12-2019
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 Feb-09-2024
18 Philips North America II May-15-2023
19 Philips North America Llc II Nov-08-2023
20 Philips North America Llc II Apr-10-2023
21 Philips North America Llc II Nov-09-2021
22 Shimadzu Medical Systems II Apr-07-2022
23 Siemens Medical Solutions USA, Inc II Jan-20-2023
24 Siemens Medical Solutions USA, Inc II Oct-21-2022
25 Siemens Medical Solutions USA, Inc II Jun-27-2022
26 Siemens Medical Solutions USA, Inc II Jan-08-2021
27 Siemens Medical Solutions USA, Inc II Aug-05-2020
28 Siemens Medical Solutions USA, Inc II Mar-07-2019
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