🏥 Medical Devices Class I - Dangerous
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
All Recalls
95,075 total recalls in our database
Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Philips Electronics North America
🏥 Medical Devices Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
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.
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
🏥 Medical Devices Class I - Dangerous
Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.
🏥 Medical Devices Class I - Dangerous
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
🏥 Medical Devices Class I - Dangerous
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
🏥 Medical Devices Class I - Dangerous
While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
🏥 Medical Devices Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Philips Electronics North America
🏥 Medical Devices Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
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.
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
🏥 Medical Devices Class I - Dangerous
Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
Wright Medical Technology
🏥 Medical Devices Class I - Dangerous
Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Philips Electronics North America
🏥 Medical Devices Class I - Dangerous
Potential risk for helium gas inside the MR examination room during a magnet quench
🏥 Medical Devices Class I - Dangerous
The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.
🏥 Medical Devices Class I - Dangerous
The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
OraSure Technologies
🏥 Medical Devices Class I - Dangerous
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
Teleflex Medical Europe
🏥 Medical Devices Class I - Dangerous
These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.
Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Terumo Cardiovascular Systems
🏥 Medical Devices Class I - Dangerous
Update to cooler-heater cleaning instructions.
🏥 Medical Devices Class I - Dangerous
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
Terumo Cardiovascular Systems
🏥 Medical Devices Class I - Dangerous
Update to cooler-heater cleaning instructions.
The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
🏥 Medical Devices Class I - Dangerous
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.