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Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips Recalls

All product recalls associated with Philips Medical Systems North America Co. Phillips.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

143

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 33581–33600 of 37665 recalls

Philips Medical Systems North America Co. Phillips: Allura Xper FD20 X-Ray System, Release 2.2, Philips Medic...

Inaccurate anatomical measurements when using the optional SmartMask feature

FDASep 24, 2007Nationwide• Philips Medical Systems North America Co. Phillips

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.

1...1678 167916801681 1682...1884

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FDASep 19, 2007Nationwide• Terumo Cardiovascular Systems Corp

Beckman Coulter Inc: Access Ultrasensitive Insulin Assay Kit, Part Number 3341...

False negative results when used to test serum samples (as compared to plasma samples).

FDASep 19, 2007Nationwide• Beckman Coulter Inc

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.

FDASep 19, 2007Nationwide• Terumo Cardiovascular Systems Corp

Smiths Medical ASD, Inc.: Portex Perfit Percutaneous Tracheostomy Tube Replacement ...

Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.

FDASep 18, 2007Nationwide• Smiths Medical ASD, Inc.

Abbott Laboratories: ARCHITECT i System Assay CD-ROM - WW (excluding USA accou...

The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. product. The assay labeling indicates that the limit flag should be set no lower than 20 ng/mL

FDASep 18, 2007Nationwide• Abbott Laboratories

Precept Medical Products, Inc.: Precept Medical Products, Tape Fog Shield Surgical Mask G...

Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff

FDASep 14, 2007Nationwide• Precept Medical Products, Inc.

Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342: HiRes 90K devices with Helix Electrodes Model CI 1400-02H...

Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.

FDASep 14, 2007Nationwide• Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342

Precept Medical Products, Inc.: Precept Medical Products, Foam Fog Shield Surgical Mask G...

Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff

FDASep 14, 2007Nationwide• Precept Medical Products, Inc.

Fertility Technology Resources, Inc.: Tucker Embryo Catheter with URM Tip, Embryo Transfer Cath...

Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.

FDASep 13, 2007CA, CO, FL +13 more• Fertility Technology Resources, Inc.

Fertility Technology Resources, Inc.: Tucker Embryo Catheter, Stylet, For use with Embryo Trans...

Expiration Date for Sterility; The 5 year dating could not be validated/supported for sterility assurance.

FDASep 13, 2007CA, CO, FL +13 more• Fertility Technology Resources, Inc.