GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Vivid 7 ultrasound system - Class 2 Recall
GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic,...
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Vivid E7 ultrasound system - Class 2 Recall
GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic...
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
Civco Medical Instruments Co. Inc. - CIVCO lnfiniti Needle Guide Bracket. - Class 2 Recall
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - T2100 Treadmill - Class 2 Recall
T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Specifically the T210 Treadmill is intended for use in Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2018 Category: Medical Devices Source Type: alerts
Toshiba American Medical Systems Inc - Aplio Iseries (i700, i800, i900) - Class 2 Recall
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2018 Category: Medical Devices Source Type: alerts
Parker Laboratories, Inc. - Sterile Aquasonic 100 Ultrasound Transmission Gel - Class 2 Recall
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 10, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Healthcare Lunar Lunar DPX NT; DPX MD - Class 2 Recall
GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Healthcare Prodigy; Prodigy Advanced - Class 2 Recall
GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Healthcare Lunar Lunar DPX Duo; DPX Bravo - Class 2 Recall
GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts
Konica Minolta Medical Imaging USA, Inc. - SONIMAGE HS1 - Class 2 Recall
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2018 Category: Medical Devices Source Type: alerts
Konica Minolta Medical Imaging USA, Inc. - SONIMAGE HS1 - Class 2 Recall
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2018 Category: Medical Devices Source Type: alerts
Konica Minolta Medical Imaging USA, Inc. - SONIMAGE HS1 - Class 2 Recall
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2018 Category: Medical Devices Source Type: alerts
Konica Minolta Medical Imaging USA, Inc. - SONIMAGE HS1 - Class 2 Recall
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON SC2000 Ultrasound System - Class 2 Recall
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2018 Category: Medical Devices Source Type: alerts
ESAOTE S.P.A. - MyLab Ultrasound System - Class 2 Recall
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2018 Category: Medical Devices Source Type: alerts
