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.

126–150 of 315

  • HighFDA (Devices)·Z-2347-2016·2016-08-17

    Philips MX 16-slice CT Systems Recalled for Software Defects

    Philips is recalling 80 MX 16-slice CT systems due to software bugs that may cause image mix-ups or scan interruptions.

    Product
    MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2385-2016·2016-08-17

    Philips Ingenuity CT Software Recall for Performance Issues

    Philips Medical Systems is recalling 205 Ingenuity CT units due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.

    Product
    Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2381-2016·2016-08-17

    Philips Brilliance iCT Recalled for Software Performance Issues

    Philips Medical Systems is recalling 335 Brilliance iCT units due to software issues in versions v4.1.3 and v4.1.5 that could affect equipment performance.

    Product
    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2383-2016·2016-08-17

    Philips CT Scanner Software Recall for Performance Issues

    Philips is recalling Ingenuity Core CT scanners due to software issues in versions v4.1.3, v4.1.4, and v4.1.5 that could affect equipment performance.

    Product
    Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2382-2016·2016-08-17

    Philips Brilliance iCT SP CT Scanner Software Recall

    Philips is recalling 57 Brilliance iCT SP CT scanners due to software issues in versions 4.1.3 and 4.1.5 that could affect equipment performance.

    Product
    Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2372-2016·2016-08-17

    Philips Ingenuity Core 128 CT Systems Recalled for Software Defect

    Philips is recalling five Ingenuity Core 128 CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2370-2016·2016-08-17

    Philips Brilliance CT 16 Power Systems Recalled for Software Defect

    Philips Medical Systems is recalling 55 Brilliance CT 16 Power systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2366-2016·2016-08-17

    Philips Brilliance 64 CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 318 Brilliance 64 Computed Tomography X-ray systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2369-2016·2016-08-17

    Philips Brilliance 16 CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 203 Brilliance 16 CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2367-2016·2016-08-17

    Philips Brilliance BigBore CT Systems Recalled for Software Defect

    Philips is recalling eight Brilliance BigBore Oncology CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance BigBore Oncology 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.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2368-2016·2016-08-17

    Philips Brilliance BigBore CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 17 Brilliance BigBore CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance BigBore Radiology 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.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2380-2016·2016-08-17

    Philips Brilliance 64 CT Scanner Software Recall

    Philips is recalling Brilliance 64 CT scanners due to software issues that could affect equipment performance.

    Product
    Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2384-2016·2016-08-17

    Philips Ingenuity CT Software Recall for Performance Issues

    Philips is recalling Ingenuity Core128 CT scanners due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.

    Product
    Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2371-2016·2016-08-17

    Philips Ingenuity Core CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 29 Ingenuity Core CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2346-2016·2016-08-17

    Philips MX 16-slice CT System Software Recall for Data Integrity Issues

    Philips is recalling 899 MX 16-slice CT systems due to software defects that may cause patient image mix-ups or scan interruptions.

    Product
    MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
    Category
    Medical Device
    Distribution
    18 states
  • SevereFDA (Devices)·Z-2114-2016·2016-07-06

    Philips Ingenuity Core 128 MRI Systems Recalled for Cover Crack Risk

    Philips is recalling 14 Ingenuity Core 128 MRI systems because a thinner plastic cover may crack, posing an injury risk to patients and staff.

    Product
    Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2113-2016·2016-07-06

    Philips Ingenuity Flex MRI Units Recalled for Cracking Cover Hazard

    Philips is recalling 10 Ingenuity Flex MRI units because a thinner plastic cover may crack, posing an injury risk to patients and staff.

    Product
    Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2115-2016·2016-07-06

    Philips Ingenuity Core MRI Scanner Recalled for Cover Crack Risk

    Philips Medical Systems is recalling Ingenuity Core MRI scanners because a thinner plastic cover may crack, posing an injury risk to patients and staff.

    Product
    Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2111-2016·2016-07-06

    Philips CT Scanner Recall Due to Potential Cover Cracking Hazard

    Philips is recalling three Brilliance CT Big Bore Oncology scanners because a thinner plastic cover may crack and cause injury to patients or staff.

    Product
    Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2117-2016·2016-07-06

    Philips Ingenuity Core CT Systems Recalled for Image Artifacts

    Philips is recalling 18 Ingenuity Core CT systems because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.

    Product
    Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner 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 taken at different angles an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2112-2016·2016-07-06

    Philips Brilliance iCT Scanner Recall Due to Cracking Cover

    Philips is recalling Brilliance iCT scanners because a design change resulted in a thinner plastic cover that may crack.

    Product
    Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2109-2016·2016-07-06

    Philips Big Bore Oncology Scanner Recalled for Incorrect Screw Material

    Philips is recalling 47 Big Bore Oncology scanners because the socket head cap screws in the Z-Axis Adjustment Plate were made of stainless steel instead of the specified alloy steel.

    Product
    Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner 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 taken at different
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2118-2016·2016-07-06

    Philips Ingenuity Core 128 CT Scanner Recalled for Image Artifacts

    Philips is recalling 19 Ingenuity Core 128 CT scanners because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.

    Product
    Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner 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 taken at different a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2110-2016·2016-07-06

    Philips Big Bore Radiology Scanner Recalled for Incorrect Screw Material

    Philips is recalling 89 Big Bore Radiology scanners because adjustment plate screws were made of stainless steel instead of the specified alloy steel.

    Product
    Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner 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 taken at differe
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2116-2016·2016-07-06

    Philips Brilliance 64 CT Scanner Recall for Image Artifacts

    Philips is recalling 94 Brilliance 64 CT scanners due to intermittent swirl-like ring artifacts on images, which may require patient rescans.

    Product
    Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner 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 taken at different angles
    Category
    Medical Device
    Distribution
    Distributed nationwide