GE Healthcare, LLC - Aisys Anesthesia System - Class 2 Recall
Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Aisys Anesthesia System - Class 2 Recall
Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI envi...
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts
Maribel ’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars
Maribel ’s Sweets Inc. of Brooklyn, NY is recalling its 2.82oz MarieBelle Japanese Matcha Japanese Green Tea and White Chocolate Bar, container code 101619, Cacao Market by MarieBelle Rosemary Truffle Salt 60% Dark Chocolate Bar, all container codes, and the Cacao Market by MarieBelle Orange Peels 60% Dar k Chocolate Bar, all container codes, because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product. (Source: FDA Food Alergies)
Source: FDA Food Alergies - October 29, 2018 Category: Food Science Source Type: alerts
Siemens Healthcare Diagnostics, Inc - ADVIA Centaur CKMB Calibrator 2pack Japan - Class 2 Recall
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 16, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare Japan Corporation - GE Healthcare Optima CT540 - Class 2 Recall
GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA 540, CT BEIJING OPTIMA 540 ASIR, CT GOLDSEAL OPTIMA 540, CT OPTIMA 540, CT OPTIMA 540 ASIR, CT OPTIMA CT540 TANG BEIJING, DISCOVERY 670 3/8 MEA PRO, HINO OPTIMA 540, HINO OPTIMA 540 ASIR, HINO OPTIMA 540 ASIR, OPTIMA 540, OPTIMA 540 ASIR, OPTIMA 540 MOBILE BEIJING, OPTIMA CT540, OPTIMA CT540 32 SLICES, OPTIMA CT540 ASIR, OPTIMA CT540 BJG SKD RUSSIA,...
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare Japan Corporation - GE Healthcare Optima CT660 - Class 2 Recall
GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only outside the U.S. under the following product names: CT OPTIMA 660, CT OPTIMA 660 LONG BJG SKD RUS, CT OPTIMA 660 LONG BJG SKD RUSSIA, CT OPTIMA 660 MID BJG SKD RUSSIA, CT OPTIMA 660 SE, CT OPTIMA 660 SE ASIR, CT660 M40 LONG, CT660 M40 MID, CT660 M40 MID WAUK SKD, CT660 M40 MID WAUK SKD BRAZ, CT660 M40 MID WAUK SKD BRAZ, OPT 660 M40 MID HINO SKD RUS, OPTIMA 660, OPTIMA 660 1.5, OPTIMA 660 1.5 BRAZIL, OPTIMA 660 1.5 BRAZIL SKD W, OPTIMA 660 1.5 BRAZIL SKD WAUK, OPTIMA 660 LONG BJG...
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare Japan Corporation - GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680 - Class 2 Recall
GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT OPTIMA 660 M40 GT1700, CT OPTIMA 660 M40 GT1700 BEIJI, CT OPTIMA 660 M40 GT1700 HINO, CT OPTIMA 660 M40 GT2000 BEIJI, CT OPTIMA 660 M40 GT2000 HINO, CT OPTIMA CT 660, CT OPTIMA CT660, CT OPTIMA CT660 M4, CT OPTIMA CT660 M40, CT REVOLUTION EVO 3.5 LONG HIN, CT REVOLUTION EVO VT2000 HINO, CT660 MAR UPGRADE, MOBILE OPTIMA CT 660, ...
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare Japan Corporation - GE Healthcare Optima CT660 - Class 2 Recall
GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING OPTIMA CT660S PRO 32 S, CT GOLDSEAL, CT GOLDSEAL OPTIMA 660, CT GOLDSEAL OPTIMA 660 UT-BUC, CT OPTIMA 660 LNG HN P20, CT OPTIMA 660 MID HN P20, CT OPTIMA 660 PRO, CT OPTIMA 660 PRO LONG BJG P2., CT OPTIMA 660 PRO MID, CT OPTIMA 660 PRO MID HN P20, CT OPTIMA 660S LNG HN P20, CT OPTIMA CT660 GT 1700, CT OPTIMA CT660 GT1700, CT OPTIMA CT660 GT1700V, CT OPTIMA CT660 PRO GT1700, CT OPTIMA CT660 PRO LNG P1.5 H, CT OPTIMA CT660 PRO MID P1.5 H, CT OPTIMA CT660 SE GT 1700, CT OPTIMA CT660 ...
Source: Medical Device Recalls - August 18, 2018 Category: Medical Devices Source Type: alerts
INO therapeutics LLC/dba ikaria - INOflo DS - Class 2 Recall
Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder of drug product. Functionality of the INOmeter: The INOmeter is affixed on top of each INOflo cylinder valve in Japan. When the healthcare provider opens the INOmeter the compressed gas cylinder valve opens to begin flow of the nitric oxide in nitrogen compressed gas. The nitric oxide gas is administered to a patient via a nitric oxide delivery device....
Source: Medical Device Recalls - August 9, 2018 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - AMIA Automated PD Cycler - Class 2 Recall
power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only) (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 3, 2018 Category: Medical Devices Source Type: alerts
Ventana Medical Systems Inc - CINtec PLUS Cytology Kit (Canada/Japan) - Class 2 Recall
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 28, 2018 Category: Medical Devices Source Type: alerts
IXIARO (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) Injection, Suspension [Valneva Scotland Ltd.]
Updated Date: Feb 13, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 13, 2018 Category: Drugs & Pharmacology Source Type: alerts
ANTI-BACTERIAL HAND SANITIZER JAPANESE CHERRY BLOSSOM (Alcohol) Gel [Bath Body Works, Inc.]
Updated Date: Dec 29, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 29, 2017 Category: Drugs & Pharmacology Source Type: alerts
ANTI-BACTERIAL HAND JAPANESE CHERRY BLOSSOM (Alcohol) Gel [Bath Body Works, Inc.]
Updated Date: Dec 29, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 29, 2017 Category: Drugs & Pharmacology Source Type: alerts
