Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
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.
Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE ...
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only...
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Burlington Medical, Wrap Aprons.
Potential for attenuation degradation over time, decreasing the lifespan.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH...
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Sterile Radiology Procedure Kits, Model Number DYNDH1491B
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
SIGNA Premier systems
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
Burlington Medical, Frontal Aprons
Potential for attenuation degradation over time, decreasing the lifespan.
Burlington Medical, Caps.
Potential for attenuation degradation over time, decreasing the lifespan.
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-...
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DY...
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120R...
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
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: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da V...
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H S...
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: d...
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2...
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLT...
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
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.
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937....
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
Burlington Medical, Kilt Blockers.
Potential for attenuation degradation over time, decreasing the lifespan.
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
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.