Philips Medical Systems (cleveland), Inc.
3630 SW 47th Avenue, Gainesville, FL, US
Registered product codes
3 product codes
Recent MDR events
1,975 on file
- PRECEDENCEFeb 27, 2025Injury3015777306-2025-000002
- DIGITALDIAGNOST 4.1 CHEST / EMERGENCYNov 6, 2024Malfunction3003768251-2024-00085
- PINNACLE 18.0Oct 18, 2024Malfunction3004022368-2024-00003
- PINNACLE 18.0Oct 18, 2024Malfunction3004022368-2024-00004
- PINNACLE3 SMART ENTERPRISE SERVERMay 7, 2024Malfunction3004022368-2024-00002
- BRIGHTVIEW GAMMA CAMERA SYSTEMFeb 13, 2024Malfunction18695454
- BRILLIANCE 64 CTSep 29, 2023MalfunctionMW5146306
- PHILLIPS INGENIA 3TMar 29, 2023InjuryMW5116124
- PINNACLE 18.0Aug 24, 2022Malfunction3004022368-2022-00005
- BRILLIANCE 64-SLICEJul 12, 2022DeathMW5110808
Recalls
414 on file
- Open, ClassifiedSep 16, 2025
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
View FDA record ↗ - Open, ClassifiedAug 1, 2025
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
View FDA record ↗ - Open, ClassifiedSep 15, 2022
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.
View FDA record ↗ - TerminatedNov 1, 2019
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
View FDA record ↗ - TerminatedNov 1, 2019
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
View FDA record ↗ - TerminatedNov 1, 2019
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
View FDA record ↗ - TerminatedNov 1, 2019
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
View FDA record ↗ - TerminatedNov 1, 2019
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
View FDA record ↗ - TerminatedAug 6, 2019
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
View FDA record ↗ - TerminatedAug 6, 2019
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
View FDA record ↗
Compliance history
Matched by FEI 3018004899.
FDA inspections
3 on file
- No Action Indicated (NAI)Jan 16, 2025
Compliance: Devices
- No Action Indicated (NAI)Jan 16, 2025
Postmarket Assurance: Devices
- No Action Indicated (NAI)Jan 16, 2025
Radiation Control and Health Safety Act
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.