All recalls7,799 total
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Neutralization Buffer may contain contaminants
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
May be temperature abused, which may result in growth of Clostridium botulinum
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Lack of Assurance of Sterility
Potential for mislabeled syringe produced by the i.v.STATION device.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Resorbable bone void filler falls outside standard specifications.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Resorbable bone void filler falls outside standard specifications.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Potential contamination with pesticides, haloxyfop and thiamethoxam
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm
Potential contamination with pesticides, haloxyfop and thiamethoxam