Philips Recalls Intellispace Portal Software Due to Missing Warning Messages
Philips is recalling 96 Intellispace Portal software units to fix a defect where the system fails to display a warning message when launching multiple patient studies.
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: The recall is classified as FDA Class II, but the source text describes a software defect involving a missing warning message without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity, representing a risk of harm where injury has not yet been reported or a minor labeling/interface error.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 96 units of Intellispace Portal software, a multimodality thin client applications server used for diagnostic viewing and clinical applications. The recall addresses several non-conformances, with the most significant issue involving the "PAC Integration" setting. This feature allows users to launch images of multiple patient studies into an application but fails to display a warning message informing the user of the action.
The affected software is distributed worldwide, including in the United States and various international locations such as Australia, Canada, and several European countries. The specific model number is 881001, and the recall covers a specific list of serial numbers provided by the manufacturer.
Healthcare facilities and users should contact Philips Medical Systems to obtain the software update that addresses these non-conformances. The update is intended to correct the missing warning message and other identified issues.
The recalled product
- Product
- Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — Software
- Affected units
- 96
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 (20)
- Model number 881001
- Serial numbers: 81172
- 79937
- 85083
- 81097
- 85145
- 79916
- 81132
- 85011
- 82020
- 85007
- 85006
- 85081
- 81028
- 80914
- 82004
- 85041
- 81180
- 82016
- 30019
Distribution
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