Philips Medical Systems Nederland B.V. recalls four IntelliSpace Cardiovascular software units distributed to facilities in Georgia, North Carolina and Texas. A software issue can display outdated information on the device. Hospitals should stop using the device immediately and follow Philips recall instructions.
Software issue that results in the display of outdated information.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for instructions. Notification method: Letter
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IntelliSpace Cardiovascular is a hospital information system used to manage cardiovascular imaging and patient data. It helps clinicians track studies and patient information across workflows.
The defect can cause the display to show information that is not current, potentially impacting clinical decisions.
No information indicates a broader industry pattern.
Hospitals may experience workflow disruption and potential misinterpretation of patient data until the software is updated or replaced.
Model number and software version appear on the device label and within the software interface. Serial numbers are on the device hardware.
Recall remedies and updated software will be issued by Philips; no timeline is provided in the notice.
Keep copies of the recall notice, device IDs, serial numbers, and all correspondence with Philips and healthcare providers.
Model No. 830089 UDI: (01)00884838122000(11)240325(10)8.0.0.0 Serial Numbers: 2210, 2050, 463, 193 Distribution: US nationwide in GA, NC, TX Sold to: Healthcare facilities via distributors (no consumer retailer listed) Price: Unknown
No injuries or incidents have been reported.
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