Philips IntelliSpace Cardiovascular Software Data Archival Failure Recall
Philips cardiovascular diagnostic software version 7.0.0.0 cannot archive, copy, or export study data, affecting 139 units distributed nationwide. Users may experience data management and workflow disruptions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class II recall involves a data management defect with no reported illnesses, injuries, or hospitalizations. The hazard is operational rather than directly patient safety-related, affecting the ability to archive, copy, or export study data.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Philips IntelliSpace Cardiovascular software, Model 830089, software version 7.0.0.0 due to a data management defect. The software is unable to archive, copy, or export study data, which prevents proper data management and workflow operations.
This recall affects 139 units of the software distributed nationwide across 21 U.S. states: Alaska, Alabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New York, Ohio, Oregon, Tennessee, Texas, Virginia, and Wisconsin.
Users should discontinue use of version 7.0.0.0 if they rely on data archival, copying, or export functions. Contact Philips Medical Systems Nederland B.V. for software updates or patches that address this data management issue.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Philips IntelliSpace Cardiovascular software, Model 830089.
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Hazard
- Affected units
- 139
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software version 7.0.0.0
- UDI (01)00884838115378(11)221214(10)7.0.0.0.
Distribution
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