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Philips Medical Systems (Cleveland) Inc

Philips Medical Systems (Cleveland) Inc Recalls

All product recalls associated with Philips Medical Systems (Cleveland) Inc.

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 2901–2920 of 3680 recalls

Philips Medical Systems (Cleveland) Inc: Philips Medical Systems, GEMINI TF 16 & 64 slice PET/CT ...

Artifacts: Artifacts may appear in some images from head scans on the CT subsystem of the GEMINI PET/CT system. Reading images with these artifacts may lead to misdiagnosis or improper treatment.

FDASep 21, 2007Nationwide• Philips Medical Systems (Cleveland) Inc

Terumo Cardiovascular Systems Corp: Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4...

False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.

FDASep 19, 2007Nationwide• Terumo Cardiovascular Systems Corp

Terumo Cardiovascular Systems Corp: Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6...

False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.

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FDASep 19, 2007Nationwide• Terumo Cardiovascular Systems Corp

Steris Corporation Hopkins Facility: Steris QFC1728 and QFC1729 Quick Connects;(used to connec...

Loose or missing adaptor: The center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor's housing. The absence of adaptor #6's center insert may affect the sterilization process of the attached endoscope.

FDASep 12, 2007Nationwide• Steris Corporation Hopkins Facility

Philips Medical Systems: Philips PageWriter Touch Cardiograph, Model: 860284, Phil...

Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.

FDASep 12, 2007Nationwide• Philips Medical Systems

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL...

The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking

FDASep 11, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch d...

Failure to operate; The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.

FDASep 10, 2007AL, AZ, FL +7 more• Terumo Cardiovascular Systems Corp

Varian Medical Systems Inc: Varian brand Clinac, Accelerator, Linear, Medical charged...

The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.

FDASep 10, 2007Nationwide• Varian Medical Systems Inc

Varian Medical Systems Inc: Varian brand Clinac, Accelerator, Linear, Medical charged...

Treatment Error: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.

FDASep 10, 2007Nationwide• Varian Medical Systems Inc

Philips Medical Systems (Cleveland) Inc: Philips Medical Systems, Cardiac Viewer or Pulmonary View...

Incorrect Measurement: Incorrect measurement will occur when the operator uses the distance or area measurement function, such as Graphic Tool line or ROI on zoomed and batch saved images from the Cardiac Viewer or Pulmonary Viewer and then views them in the CT Viewer or on a PACS System.

FDASep 10, 2007AL, AK, AZ +44 more• Philips Medical Systems (Cleveland) Inc

BD Biosciences, Systems & Reagents: CellQuest Pro SW, version 4.0.2. and later; Becton Dickin...

Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.

FDASep 7, 2007Nationwide• BD Biosciences, Systems & Reagents

Ventana Medical Systems Inc: Ventana Medical System's Symphony Staining System, KPA, M...

Shock hazard: Devices released prior to full testing; the configuration of the Symphony instrument during Hi pot testing procedures did not completely evaluate all components in the test loop. In specific circumstances, a shock hazard exists.

FDASep 6, 2007Nationwide• Ventana Medical Systems Inc

BD Diagnostic Systems Lee Laboratories: BD DifcoTM Neisseria Meningitidis Antisera Group Y, 2288...

Exhibits cross reactivity with Neisseria meningitides Group W135.

FDASep 6, 2007Nationwide• BD Diagnostic Systems Lee Laboratories

Philips Medical Systems: HeartStart XL Defibrillator/Monitor, Model: M4735A

Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly.

FDASep 4, 2007PR• Philips Medical Systems

GE Healthcare Clinical Systems: GE LOGIQ 3 Expert ultrasound scanner with software versio...

Inaccurate guidelines: The BE9C is an optional, small radius Bi-planar convex probe intended for use with the LOGIQ 3 Expert system in Urology application. An attempt by the user to activate the biopsy guidelines while this probe is in use will cause incorrect guidelines to be displayed on the image. The incorrect guidelines are recognized by their orientation that is left/right reversed from t

FDASep 4, 2007AL, NY• GE Healthcare Clinical Systems

Stryker Howmedica Osteonics Corp.: Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA...

Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.

FDAAug 30, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: HA Solid Back Acetabular Shell; Arc Deposited HA Coated I...

FDAAug 30, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Philips Medical Systems North America Co. Phillips: Philips Medical System - BV Pulsera Mobile C-arms with Re...

System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.

FDAAug 23, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: Philips Medical System - Endura X-Ray Systems (Release 2)...

System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.

FDAAug 23, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Inotech Biosystems Intl., Inc: Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10m...

Erroneous Coagulation Tests

FDAAug 20, 2007Nationwide• Inotech Biosystems Intl., Inc