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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

37,779 Total Recalls

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).

Olympus Corporation of the Americas

Class I - Dangerous

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Nov 25, 2024 Surgical Instruments Nationwide View Details →

Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component

Ortho-Clinical Diagnostics

Class I - Dangerous

The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

Dec 19, 2024 Diagnostic Equipment Nationwide View Details →

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424030 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).

Olympus Corporation of the Americas

Class I - Dangerous

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Nov 25, 2024 Surgical Instruments Nationwide View Details →

BD Pyxis MedStation 4000 Main, REF 303

CareFusion 303

Class I - Dangerous

Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,

Feb 14, 2023 Other Medical Devices View Details →

Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.

St. Jude Medical

Class I - Dangerous

Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.

Nov 6, 2024 Diagnostic Equipment View Details →

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).

Olympus Corporation of the Americas

Class I - Dangerous

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Nov 25, 2024 Surgical Instruments Nationwide View Details →

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).

Olympus Corporation of the Americas

Class I - Dangerous

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Nov 25, 2024 Surgical Instruments Nationwide View Details →

BD Pyxis Med 4000 Auxiliary (AUX), REF 314

CareFusion 303

Class I - Dangerous

Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,

Feb 14, 2023 Other Medical Devices View Details →

BD Pyxis MedStation ES (Med ES Main), REF 323

CareFusion 303

Class I - Dangerous

Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,

Feb 14, 2023 Other Medical Devices View Details →

BD Pyxis MedStation 4000 AUX, REF 306

CareFusion 303

Class I - Dangerous

Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,

Feb 14, 2023 Other Medical Devices View Details →

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424110Âŋ Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).

Olympus Corporation of the Americas

Class I - Dangerous

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Nov 25, 2024 Surgical Instruments Nationwide View Details →