Other Medical Devices

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Potential for attenuation degradation over time, decreasing the lifespan.

Potential for attenuation degradation over time, decreasing the lifespan.

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.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Potential for attenuation degradation over time, decreasing the lifespan.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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.

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

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.

Potential for attenuation degradation over time, decreasing the lifespan.

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.

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.

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.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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.