GE Healthcare, LLC: Medical Device Recalls in 2018

According to to data from the FDA, there were 47 medical device recalls made by GE Healthcare, LLC in 2018. See the details of the recalls below.

You can see similar recalls for other firms.

• 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.
• DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.
• GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
• GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
• 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 environment.
• Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPLAY KIT 11.X DANISH, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. 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 environment.
• GE Healthcare Millennium MC
• DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
• Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect.
• Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
• Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
• Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
• Revolution CT 160 1.5D STD WAUK
• Discovery MI Digital Ready
• Optima CT 540
• Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
• CT Goldseal BrightSpeed 16 PWR TIO 2 YR
• Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
• Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three cables. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected.
• Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.
• Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
• Optima CT 520
• Discovery RT labeled as: a. MID BJG; b. HVY BJG
• CT Goldseal Optima CT 600
• GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.
• Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
• Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
• PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport.
• B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
• GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculoskeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (vascular).
• Discovery NM/CT 670 Pro, model 5376204-70-54
• B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
• Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
• Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
• B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
• Panda Wall Mount warmer. Infant radiant warmer
• Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
• Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
• Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
• Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
• Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
• PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
• Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
• Discovery NM/CT 670 ES, model 5376204-70-57
• Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
• Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
• Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.