Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-04-25FDA-DeviceOraSure Technologies, Inc.Class IIICocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
- 2018-04-25FDA-DeviceTerumo Cardiovascular Systems CorporationClass IISarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Update to cooler-heater cleaning instructions.
- 2018-04-25FDA-DeviceTerumo Cardiovascular Systems CorporationClass IISarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Update to cooler-heater cleaning instructions.
- 2018-04-25FDA-DeviceTerumo Cardiovascular Systems CorporationClass IITerumo 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.
Update to cooler-heater cleaning instructions.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIIQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIIngenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIIngenuity Core - Model no. 728321, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIIngenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIIngenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- 2018-04-25FDA-DeviceTeleflex Medical Europe LtdClass IITeleflex 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.
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.
- 2018-04-25FDA-DeviceSiemens Medical Solutions USA, IncClass IIPRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
- 2018-04-25FDA-DeviceSiemens Medical Solutions USA, IncClass IIONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
- 2018-04-25FDA-DeviceSiemens Medical Solutions USA, IncClass IIONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
- 2018-04-25FDA-DeviceSiemens Medical Solutions USA, IncClass IIONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
- 2018-04-25FDA-DeviceSiemens Medical Solutions USA, IncClass IIONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
- 2018-04-25FDA-DeviceSiemens Medical Solutions USA, IncClass IIMEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
Surview scan with tube current lower than 30 mA is unable to be initialized.
- 2018-04-25FDA-DeviceGE Medical Systems Ultrasound & Primary Care Diagnostics, LLClass IIGE 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.
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.
- 2018-04-25FDA-DeviceGE Medical Systems Ultrasound & Primary Care Diagnostics, LLClass IIGE 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.
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.
- 2018-04-25FDA-DeviceGE Medical Systems Ultrasound & Primary Care Diagnostics, LLClass IIGE 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.
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.
- 2018-04-25FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIIngenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion view
Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
- 2018-04-25FDA-DeviceNeuroLogica CorporationClass IISolid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
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.
- 2018-04-25FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIFluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.
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