TPLC - Total Product Life Cycle

show TPLC since

Device	system, tomography, computed, emission
Regulation Description	Emission computed tomography system.
Product Code	KPS
Regulation Number	892.1200
Device Class	2

Premarket Reviews
Manufacturer	Decision
BRACCO DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BRIGHTONIX IMAGING
	SUBSTANTIALLY EQUIVALENT	1
CANON MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
COMBINOSTICS OY
	SUBSTANTIALLY EQUIVALENT	1
EVER FORTUNE.AI, CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	4
GE MEDICAL SYSTEMS ISRAEL
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
	SUBSTANTIALLY EQUIVALENT	2
GE MEDICAL SYSTEMS SCS
	SUBSTANTIALLY EQUIVALENT	2
GE MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.
	SUBSTANTIALLY EQUIVALENT	1
HERMES MEDICAL SOLUTIONS AB
	SUBSTANTIALLY EQUIVALENT	2
MCGOVERN MEDICAL SCHOOL
	SUBSTANTIALLY EQUIVALENT	2
MEDISO MEDICAL IMAGING SYSTEMS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
	SUBSTANTIALLY EQUIVALENT	2
POSITRIGO AG
	SUBSTANTIALLY EQUIVALENT	1
PRESCIENT IMAGING, LLC
	SUBSTANTIALLY EQUIVALENT	1
RADIALIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
RAYSOLUTION HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	10
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHINEERS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS USA, INC.
	SUBSTANTIALLY EQUIVALENT	10
SPECTRUM DYNAMICS MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	2
SUBTLE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNTERMED
	SUBSTANTIALLY EQUIVALENT	1
TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	28	28
Improper or Incorrect Procedure or Method	14	14
Unintended System Motion	12	12
Use of Device Problem	10	10
Fail-Safe Problem	8	8
Adverse Event Without Identified Device or Use Problem	6	6
No Apparent Adverse Event	5	5
Insufficient Information	4	4
Smoking	3	3
Leak/Splash	2	2
Device Handling Problem	2	2
Device Dislodged or Dislocated	2	2
Loss of Data	2	3
Unintended Collision	2	2
Signal Artifact/Noise	1	1
Radiation Output Problem	1	1
Malposition of Device	1	1
Output Problem	1	1
Poor Quality Image	1	1
Positioning Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Misassembled During Installation	1	1
Structural Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Detachment of Device or Device Component	1	1
Computer Software Problem	1	1
Fracture	1	1
Appropriate Term/Code Not Available	1	1
Naturally Worn	1	1
Difficult to Open or Close	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	64	64
Laceration(s)	14	14
Bone Fracture(s)	12	12
Insufficient Information	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Head Injury	3	3
Crushing Injury	3	3
Fall	3	3
Hematoma	2	2
Pain	2	2
Damage to Ligament(s)	1	1
Stroke/CVA	1	2
Hypersensitivity/Allergic reaction	1	1
Hip Fracture	1	1
Unspecified Gastrointestinal Problem	1	1
Muscle Weakness	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Hernia	1	1
Limb Fracture	1	1
Radiation Burn	1	1
Hemorrhage/Bleeding	1	1
No Consequences Or Impact To Patient	1	1
Bruise/Contusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Canon Medical System, USA, INC.	II	Nov-01-2024
2	Canon Medical System, USA, INC.	II	Oct-19-2021
3	GE Healthcare, LLC	II	May-11-2021
4	GE Healthcare, LLC	II	Jan-13-2021
5	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	II	Jan-16-2026
6	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	II	Jan-09-2026
7	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	II	Oct-23-2025
8	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	II	Jul-08-2025
9	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	II	Jan-10-2025
10	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	II	Jun-07-2024
11	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	I	Feb-08-2023
12	Hermes Medical Solutions AB	II	Dec-12-2024
13	Philips North America	I	Feb-02-2024
14	Philips North America	II	Jan-05-2024
15	Philips North America Llc	II	Nov-24-2021
16	Philips North America Llc	II	Jun-30-2021
17	Shanghai United Imaging Healthcare Co., Ltd.	II	Apr-07-2023
18	Shanghai United Imaging Healthcare Co., Ltd.	II	Oct-13-2022
19	Shanghai United Imaging Healthcare Co., Ltd.	II	Sep-29-2021
20	Siemens Medical Solutions USA, Inc.	II	Jul-28-2023
21	Siemens Medical Solutions USA, Inc.	II	Feb-13-2023
22	Siemens Medical Solutions USA, Inc.	II	Apr-07-2022