PHILIPS MEDICAL SYSTEMS NEDERLAND B.V Azurion 7 M12; System Code: (1)722078, (2)722223 recall — FDA Z-1677-2026
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
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Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
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…
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…
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
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…
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
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…
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
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…
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
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…
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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…
Increased risk of purge leaks with Generation 1 purge cassettes.
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…
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…
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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…
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
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.…
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Browse recent months with enough recall history for useful comparison.