Philips Recalls IntelliSpace Portal Software Due to MUGA Scan Display Error
Philips Medical Systems is recalling IntelliSpace Portal software versions DX/HX/EX, IX, and LX SPECT because reopening MUGA scan bookmarks may display incorrect ejection fraction values.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a software display error without reporting any specific injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 1,099 units of IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT software. The affected products are multimodality thin-client applications servers that deliver diagnostic viewing and clinical applications to the enterprise. The software allows multiple users to remotely access the system from compatible computers on a network to process multimodality DICOM images.
The recall is due to a software issue identified in the NM Cardiac Application. Specifically, when a user reopens a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan, the ejection fraction (EF) displayed may not match the ejection fraction originally displayed when the bookmark was first created. This discrepancy could lead to incorrect clinical data being viewed.
The affected units were distributed worldwide, including all 50 U.S. states, Washington D.C., and numerous international countries. Healthcare facilities and users of the affected software versions should contact Philips Medical Systems for instructions on how to resolve the issue or obtain a software update.
The recalled product
- Product
- IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 1,099
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)
- ISP DX/HX/EX
- 881035 40084 40093 40087 40133 40141 40033 40134 400226 40003 400227 40001
Distribution
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