Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-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.
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. E...
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.
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, 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.
Automated Impella Controller (AIC), labeled as the following with corresponding ...
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only...
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Allura Xper FD20/10; System Code: 722029;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
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.
Philips Respironics Trilogy Evo O2, 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.
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Burlington Medical, Demi Half Aprons.
Potential for attenuation degradation over time, decreasing the lifespan.
Burlington Medical, Kilt
Potential for attenuation degradation over time, decreasing the lifespan.
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identi...
Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.
Burlington Medical, Thyroid Shield.
Potential for attenuation degradation over time, decreasing the lifespan.
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
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.
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Surgical light assembly may not adequate support the weight of the ceiling cover.
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
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.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuo...
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-us...
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
BD Kiestra" ReadA; Catalog No.: 446948.
In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.