🔍 RecallPedia

All Recalls

95,114 total recalls in our database

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The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.

Ge Healthcare

🏥 Medical Devices Class I - Dangerous

GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose value on the live update screen from AKR / CAK to DAP. All systems sold to customers in the US that leave GEHC Surgery (the place of manufacture) are configured to display AKR / CAK when they leave the factory. An FSE changing the dose display, per the customer request, to display DAP instead does not comply to 21CFR 1020.32(k), which requires fluoroscopic equipment manufactured on or after June 10, 2006 to display continuous updates of AKR and CAK values.

May 8, 2020 Diagnostic Equipment Nationwide View Details →

Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk.

Aug 14, 2020 Diagnostic Equipment Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

🏥 Medical Devices Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

Stimwave Technologies

🏥 Medical Devices Class I - Dangerous

The product contains a non-functional component not referenced in product labeling.

Jul 15, 2020 Other Medical Devices Nationwide View Details →

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.

Exactech

🏥 Medical Devices Class I - Dangerous

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.

Aug 10, 2020 Other Medical Devices View Details →

StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

Stimwave Technologies

🏥 Medical Devices Class I - Dangerous

The product contains a non-functional component not referenced in product labeling.

Jul 15, 2020 Other Medical Devices Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

🏥 Medical Devices Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

🏥 Medical Devices Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

Stimwave Technologies

🏥 Medical Devices Class I - Dangerous

The product contains a non-functional component not referenced in product labeling.

Jul 15, 2020 Other Medical Devices Nationwide View Details →

Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic purposes.

Remel Europe

🏥 Medical Devices Class I - Dangerous

Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing, resulting in the potential for false negative results for serotypes 1 and 3

Jul 23, 2020 Diagnostic Equipment Nationwide View Details →

Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may stop functioning and all vital signs are lost

Jul 24, 2020 Diagnostic Equipment Nationwide View Details →