Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 9 months ago
Brand Name: EDAN Product Name: Fetal Monitor Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm…
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Class II · 9 months ago
Raysearch Laboratories Ab Brand Name: RayStation Product Name: RayStation/RayPlan recall: Potential for the invalidation for calculated radiation dose does not work
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for…
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Class II · 9 months ago
Raysearch Laboratories Ab Brand Name: RayStation Product Name: RayStation/RayPlan recall: Potential for the invalidation for calculated radiation dose does not work
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for…
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: 1) Robotic recall: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the…
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Class II · 9 months ago
Philips Medical Systems Nederland B.v. Allura Xper FD20 recall: Philips has identified that in a limited number of impacted systems the drip
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field…
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Class II · 9 months ago
Philips Medical Systems Nederland B.v. Allura Xper FD10 recall: Philips has identified that in a limited number of impacted systems the drip
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field…
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Class II · 9 months ago
Heraeus Medical GmbH Brand Name: Palacos Product Name: Palacos MV+G pro 40 recall: increase of complaints regarding the breakage of the ampoules within
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors…
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Class II · 9 months ago
Medline Kits containing B. Braun IV Administration Sets and Pump recall: Medline kits contain B. Braun IV Administration Sets and Pump Administration
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the…
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Class II · 9 months ago
Medline Kits containing B. Braun IV Administration Sets and Pump recall: Medline kits contain B. Braun IV Administration Sets and Pump Administration
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the…
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Class II · 9 months ago
Ge Medical Systems Israel, Functional Imaging Maxxus, System, Tomography recall: GE HealthCare has become aware that certain Nuclear Medicine systems
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted…
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Class II · 9 months ago
Heraeus Medical GmbH Brand Name: Palacos Product Name: Palacos R pro 40 recall: increase of complaints regarding the breakage of the ampoules within
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors…
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Class II · 9 months ago
C-Rad Positioning Ab Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/ recall: Due to issues with the system's stereotactic radiosurgery (SRS) treatment
Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain…
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Class II · 9 months ago
Philips Medical Systems Nederland B.v. Allura Xper FD20 Biplane recall: Philips has identified that in a limited number of impacted systems the drip
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field…
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Class II · 9 months ago
Philips Medical Systems Nederland B.v. Allura Xper FD20 OR Table recall: Philips has identified that in a limited number of impacted systems the drip
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field…
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Class II · 9 months ago
Medline Kits containing B. Braun IV Administration Sets and Pump recall: Medline kits contain B. Braun IV Administration Sets and Pump Administration
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the…
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Class II · 9 months ago
Medline Kits containing B. Braun IV Administration Sets and Pump recall: Medline kits contain B. Braun IV Administration Sets and Pump Administration
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the…
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Class II · 9 months ago
Ge Medical Systems Israel, Functional Imaging SMV DSX New Line, System recall: GE HealthCare has become aware that certain Nuclear Medicine systems
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted…
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Class II · 9 months ago
Ge Medical Systems Israel, Functional Imaging SMV BodyTrack, System recall: GE HealthCare has become aware that certain Nuclear Medicine systems
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted…
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: 1) WCH recall: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the…
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: 1) Thoracic recall: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the…
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Class II · 9 months ago
Boston Scientific Coyote Over-The-Wire PTA Balloon Dilation Catheter recall: Boston Scientific is initiating the removal of certain batches of Coyote"
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon…
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Class II · 9 months ago
Medtronic Inc Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 recall: Stents may be impacted by a Nitinol anomaly which causes a reduced stent
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may…
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Class II · 9 months ago
ICU Medical, Inc. Plum Duo Infusion System, List Number 40002-04-01 recall: ICU Medical received one lot of defective primary speakers from our supplier
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in…
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Class II · 9 months ago
Thoratec LLC CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016 recall: Acute circulatory support system pump may not fit into the motor and reports
Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the…