Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120U...
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Burlington Medical, Protective Sleeves.
Potential for attenuation degradation over time, decreasing the lifespan.
MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Vue Motion V12. Product Number: 1017979.
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH...
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT...
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradis...
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
MiniMed 620G Insulin Pump (MMT-1750)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Allura Xper FD20/15; System Code: 722058;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradis...
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH...
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Allura Xper FD20/15 OR Table; System Code: 722059;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci...
Due to increased complaints for broken/frayed grip cables for reusable instruments.
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Allura Xper FD10C; System Code: 722001;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE...
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
Azurion 5 M12; System Code: (1)722227, (2)722231;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11...
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci...
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Burlington Medical, Leg Wraps.
Potential for attenuation degradation over time, decreasing the lifespan.