A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
Glaucoma Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Pediatric Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Custom Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation.
Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table.
Standard Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Vein & Vascular Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Hand Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
ENT Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Hand Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Face Lift Pack - contains Devon Light Glove Used during surgery
Stradis Healthcare
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.