Manufacturer

Philips Medical Systems (Cleveland), Inc.

315 recalls in our database name Philips Medical Systems (Cleveland), Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 315
Critical: 0
Severe: 26
Most recent: 2025-09-24

Of the 315 recalls from Philips Medical Systems (Cleveland), Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 26 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

251–275 of 315

HighFDA (Devices)·Z-0979-2015·2015-01-21
Philips CT Systems Recalled for Improper Vertical Motor Assembly
Philips is recalling Brilliance and Ingenuity CT systems because improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
Product
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0473-2015·2014-12-03
Philips IntelliSpace Portal Software Defect May Display Incorrect Cardiac Measurements
Philips is recalling 32 IntelliSpace Portal systems due to a software defect that may display incorrect cardiac and aortic anatomy measurements used for sizing Transcatheter heart valves.
Product
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0450-2015·2014-12-03
Philips BrightView Ultrasound Systems Recalled for Software Issues
Philips Medical Systems is recalling 85 BrightView ultrasound systems worldwide due to software issues. The voluntary recall was initiated in November 2014.
Product
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-0190-2015·2014-11-19
Philips MX 16-slice CT Scanner Recalled for Incorrect Image Orientation
Philips Medical Systems is recalling 708 MX 16-slice CT Scanner Systems because scan images may display left and right sides reversed, potentially leading to misinterpretation of patient position.
Product
MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY tra
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-2711-2014·2014-10-08
Philips Ingenuity CT Scanners Recalled for Image Exposure Mislabeling
Philips Medical Systems is recalling 79 Ingenuity CT scanners because they may mislabel the order of image exposures, potentially affecting clinical interpretation.
Product
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-2678-2014·2014-10-01
Philips CT Scanner Recall Due to Inaccurate Extended Display Reconstruction
Philips Medical Systems is recalling 61 CT scanners because the Extended Display Field of View reconstruction feature produces inaccurate CT numbers and anatomy.
Product
No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-2709-2014·2014-10-01
Philips Brilliance CT System Recalled for Finger Squeeze Hazard
Philips is recalling 364 Brilliance CT systems due to a gap in the tilt stand covers that can squeeze fingers during gantry movement.
Product
Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-2664-2014·2014-09-24
Philips CT Systems Recalled for Software Image Overlap Defect
Philips is recalling Brilliance 64 and Ingenuity CT systems because CIRS 4.0 Beta 2 software may cause images to overlap during reconstruction.
Product
The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equip
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2666-2014·2014-09-24
Philips Brilliance CT Big Bore Recalled for Emergency Stop Defect
Philips Medical Systems is recalling 257 Brilliance CT Big Bore systems because the emergency stop function may activate while the system is idle, halting all movements and scans.
Product
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2237-2014·2014-08-20
Philips Recalls IntelliSpace Portal Software Due to MUGA Scan Display Error
Philips Medical Systems is recalling IntelliSpace Portal software versions DX/HX/EX, IX, and LX SPECT because reopening MUGA scan bookmarks may display incorrect ejection fraction values.
Product
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterpr
Category
Medical Device
Distribution
38 states
ModerateFDA (Devices)·Z-2037-2014·2014-07-16
Philips Gemini TF PET/CT Systems Recalled for E-Stop Malfunction
Philips is recalling 33 Gemini TF PET/CT systems because a software error can prevent the emergency stop from closing, rendering the equipment inoperable for clinical use.
Product
GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1982-2014·2014-07-09
Philips BrightView XCT Gamma Camera Recall for Flat Panel Display Defect
Philips Medical Systems is recalling 407 BrightView XCT and BrightView X- gamma cameras because the Flat Panel Display may fail to remain securely locked in the deployed position.
Product
BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging.
Category
Medical Device
Distribution
32 states
ModerateFDA (Devices)·Z-1745-2014·2014-07-02
Philips Brilliance CT Big Bore Recalled for Radio Frequency Emission Tolerance Issues
Philips is recalling 454 Brilliance CT Big Bore systems because internal testing found radio frequency emissions exceeded IEC 60601-1-2 standards.
Product
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-secti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1722-2014·2014-06-11
Philips CT Scanners Recalled for Disengaged Service Latch
Philips Medical Systems is recalling 6,839 CT scanners worldwide because a service latch may disengage, causing the table top to become free-floating.
Product
Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1678-2014·2014-06-11
Philips IntelliSpace Portal Software Recall for SPECT Reconstruction Errors
Philips Medical Systems is recalling IntelliSpace Portal software because SPECT reconstructions may lack scatter correction or apply resolution recovery incorrectly.
Product
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1510-2014·2014-05-07
Philips ADAC Nuclear Gamma Cameras Recalled for Potential Patient Contact
Philips Medical Systems is recalling 1,043 ADAC nuclear gamma cameras because a belt slippage issue could cause the detector head to drift and contact patients.
Product
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for in
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1461-2014·2014-04-23
Philips CT Scanners Recalled for Defective Service Latch Component
Philips Medical Systems is recalling 135 CT scanners because a defective service latch component can cause the patient table top to become free-floating.
Product
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1464-2014·2014-04-23
Philips Ingenuity Core 128 CT Systems Recalled for Software Reconstruction Failures
Philips is recalling 116 Ingenuity Core 128 CT systems worldwide because a software upgrade caused intermittent reconstruction failures.
Product
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1312-2014·2014-04-09
Philips Pinnacle3 Radiation Therapy Planning System Software Recall
Philips is recalling Pinnacle3 Radiation Therapy Planning System software version 9.0 due to a defect that can cause incorrect beam geometry.
Product
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
Category
Medical Device
Distribution
49 states
SevereFDA (Devices)·Z-1074-2014·2014-03-05
Philips BrightView Gamma Cameras Recalled for Patient Contact Risk
Philips is recalling 1,143 BrightView gamma cameras because a positioning error can cause detectors to contact patients during imaging.
Product
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomog
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0979-2014·2014-02-19
Philips Gemini TF Big Bore PET/CT Systems Recalled for Mechanical Binding
Philips is recalling 47 Gemini TF Big Bore PET/CT systems because the patient table can mechanically bind, causing an automatic emergency stop and incomplete scans.
Product
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-0932-2014·2014-02-12
Philips Diagnostic Imaging Systems Recalled for Database Lockup
Philips Medical Systems is recalling 386 diagnostic imaging systems because the PET Reconstruction Server database may randomly lock up, preventing PET acquisitions and resulting in incomplete studies.
Product
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-0831-2014·2014-02-05
Philips Brilliance iCT Systems Recalled for Potential Image Artifacts
Philips Medical Systems is recalling Brilliance iCT and iCT SP systems because an artifact resembling a thrombus may appear on images.
Product
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment su
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0791-2014·2014-02-05
Philips Brilliance CT Systems Recalled for Dose Calculation Issue
Philips is recalling 23 Brilliance CT systems because the DoseRight feature may suggest higher radiation doses for large children than expected.
Product
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0832-2014·2014-02-05
Philips Brilliance iCT Computed Tomography Systems Recalled for Image Artifacts
Philips is recalling seven Brilliance iCT and iCT SP CT scanners because patient images exhibited ring artifacts.
Product
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray tr
Category
Medical Device
Distribution
Distributed nationwide