The Recall Desk

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.

26–50 of 315

  • SevereFDA (Devices)·Z-0544-2019·2018-12-12

    Philips Brilliance 40 CT Systems Recalled for Gantry Cover Separation Risk

    Philips is recalling 6,343 Brilliance 40 CT systems nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.

    Product
    Brilliance 40, Model 728235 Product Usage: 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 analysts and displa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0546-2019·2018-12-12

    Philips Brilliance 16 Slice CT Scanner Recall for Cover Separation

    Philips is recalling Brilliance 16 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or fall.

    Product
    Brilliance 16 Slice (Air), Model 728246 Product Usage: 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 analyst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2019·2018-12-12

    Philips Brilliance 16 Slice CT Scanner Recalled for Gantry Cover Separation Risk

    Philips Medical Systems is recalling 6,343 Brilliance 16 Slice CT scanners nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.

    Product
    Brilliance 16 Slice (Power), Model 728240 Product Usage: 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 analy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0543-2019·2018-12-12

    Philips Brilliance 64 CT Scanner Recall for Gantry Cover Separation Risk

    Philips Medical Systems is recalling Brilliance 64 CT scanners due to a potential fiberglass resin separation that could cause the gantry front cover to fail and fall.

    Product
    Brilliance 64, Model 728231 Product Usage: 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 analysts and displ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2019·2018-12-12

    Philips Brilliance 10 Slice CT Scanner Recalled for Gantry Cover Failure Risk

    Philips is recalling Brilliance 10 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover and metal support to fail or fall.

    Product
    Brilliance 10 Slice (Air), Model 728251 Product Usage: 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 analyst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0548-2019·2018-12-12

    Philips Brilliance 6 Slice CT Scanner Recalled for Gantry Cover Separation Risk

    Philips Medical Systems is recalling Brilliance 6 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or fall.

    Product
    Brilliance 6 Slice (Air), Model 728256 Product Usage: 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 analysts
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling 145 CT scanners with software version 4.2.0 because the Calcium Score report may display confusing plaque analyses, potentially leading to patient mistreatment.

    Product
    Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0311-2019·2018-11-07

    Philips Brilliance iCT SP CT Scanners Recalled for Misleading Calcium Score Reports

    Philips is recalling 626 Brilliance iCT SP CT scanners because specific software versions generate confusing calcium score reports that may lead to patient mistreatment.

    Product
    Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2019·2018-11-07

    Philips Ingenuity CT Software Recall for Misleading Calcium Score Reports

    Philips is recalling Ingenuity CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.

    Product
    Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: 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 includ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2019·2018-11-07

    Philips IQon Spectral CT Software Recall for Misleading Calcium Score Reports

    Philips is recalling IQon Spectral CT scanners with specific software versions because the Calcium Score report provides confusing and potentially misleading plaque analysis data.

    Product
    IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: 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 devic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0310-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling Ingenuity Core 128 CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.

    Product
    Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0302-2019·2018-11-07

    Philips Recalls Vereos PET/CT Software Due to Image Errors

    Philips Medical Systems is recalling 61 units of Vereos PET/CT software version 2.0.1 due to errors that may produce incorrect images or disrupt procedures.

    Product
    Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2019·2018-11-07

    Philips Brilliance iCT Scanners Recalled for Misleading Calcium Score Reports

    Philips is recalling Brilliance iCT scanners because software errors create confusing calcium score reports that may lead to patient mistreatment.

    Product
    Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: 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 incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling Ingenuity Core CT scanners with software version 4.1.6 because the Calcium Score report may display confusing plaque analyses, potentially leading to patient mistreatment.

    Product
    Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: 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 incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0303-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling 145 CT scanners because software version 4.2.0 generates confusing calcium score reports that may lead to patient mistreatment.

    Product
    Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2019·2018-11-07

    Philips Brilliance 64 CT Scanner Software Recall for Misleading Reports

    Philips is recalling Brilliance 64 CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.

    Product
    Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: 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 inclu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2496-2018·2018-07-25

    Philips Ingenuity Digital PET/CT System Recall for Pallet Assembly Defect

    Philips is recalling 32 Ingenuity Digital PET/CT Systems because a block connecting the patient pallet to the couch may be assembled incorrectly, potentially causing a misaligned screw.

    Product
    Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)9000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2018·2018-07-04

    Philips Ingenuity Core128/Elite X-Ray Tube Recall for Oil Leakage

    Philips is recalling specific Ingenuity Core128/Elite X-ray tubes due to a production defect that allows oil leakage, posing a risk to patients and users.

    Product
    Ingenuity Core128/Elite China 728324
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2274-2018·2018-07-04

    Philips Ingenuity Core X-Ray Tube Recall for Oil Leakage Risk

    Philips is recalling 28 Ingenuity Core systems due to a production defect in the X-Ray Tube that allows oil leakage, posing a risk to patients or users.

    Product
    Philips Ingenuity Core 728321
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2176-2018·2018-06-20

    Philips Brilliance 16 P CT Systems Recalled for Head Holder Contact Risk

    Philips is recalling 20 Brilliance 16 P CT systems because the patient support head holder may contact the back ISO shelter wall, posing a risk of serious injury.

    Product
    Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2175-2018·2018-06-20

    Philips Brilliance 16 CT System Recalled for Head Holder Contact Hazard

    Philips is recalling two Brilliance 16 CT systems because the patient support head holder may contact the back ISO shelter wall, posing a risk of serious injury.

    Product
    Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2174-2018·2018-06-20

    Philips Brilliance 64 CT System Recalled for Patient Support Head Holder Hazard

    Philips is recalling three Brilliance 64 CT systems because the patient support head holder could contact the back ISO shelter wall, posing a risk of serious injury.

    Product
    Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    6 states