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 Code	JAA
Regulation Number	892.1650
Device Class	2

Premarket Reviews
Manufacturer	Decision
AGFA N.V.
	SUBSTANTIALLY EQUIVALENT	1
APELEM-DMS GROUP
	SUBSTANTIALLY EQUIVALENT	1
CANON MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
DORNIER MEDTECH AMERICA
	SUBSTANTIALLY EQUIVALENT	1
DORNIER MEDTECH AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMAGING ENGINEERING, LLC
	SUBSTANTIALLY EQUIVALENT	2
NRT X-RAY A/S
	SUBSTANTIALLY EQUIVALENT	1
OMEGA MEDICAL IMAGING, LLC
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS MEDICAL SYSTEMS DMC GMBH
	SUBSTANTIALLY EQUIVALENT	3
VAREX IMAGING CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ZIEHM IMAGING GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Operational Issue	34	34
Detachment of Device or Device Component	19	19
Unintended Movement	14	14
Mechanical Problem	9	9
Device Fell	8	8
No Display/Image	7	7
Radiation Output Failure	7	7
Display or Visual Feedback Problem	7	7
Use of Device Problem	6	6
Device Handling Problem	6	6
Unintended System Motion	6	6
Unintended Collision	5	5
Break	5	5
Output Problem	5	5
Unexpected Shutdown	3	3
Poor Quality Image	3	3
Insufficient Information	3	3
Material Twisted/Bent	2	2
Patient Device Interaction Problem	2	2
Product Quality Problem	2	2
Patient Data Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Activation Failure	2	2
Device Dislodged or Dislocated	2	2
Material Integrity Problem	2	2
Application Program Freezes, Becomes Nonfunctional	2	2
Smoking	2	3
Electrical /Electronic Property Problem	2	2
Mechanical Jam	2	2
Power Problem	1	1
Protective Measures Problem	1	1
Connection Problem	1	1
Insufficient Cooling	1	1
Inappropriate or Unexpected Reset	1	1
Deformation Due to Compressive Stress	1	1
Loss of Data	1	1
Material Deformation	1	1
Computer Operating System Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Mechanics Altered	1	1
No Device Output	1	1
Flare or Flash	1	1
Difficult or Delayed Activation	1	1
Component Missing	1	1
Imprecision	1	1
Material Fragmentation	1	1
Misassembled During Installation	1	1
Moisture Damage	1	1
Contamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	118	120
Insufficient Information	15	15
Radiation Exposure, Unintended	4	4
Pain	3	3
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
Dizziness	1	1
Vascular Dissection	1	1
Exsanguination	1	1
Bone Fracture(s)	1	1
Paralysis	1	1
Needle Stick/Puncture	1	1
Discomfort	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Sore Throat	1	1

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