Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1987-2012·Announced 2012-07-18

Philips Medical Systems Recalls IntelliSpace Portal and Extended Brillance Workspace Software

Philips Medical Systems is recalling 38 units of IntelliSpace Portal and Extended Brillance Workspace software due to inconsistent diagnostic results when using specific time-based methods.

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, and the hazard involves inconsistent diagnostic software results without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 38 units of IntelliSpace Portal software and Extended Brillance Workspace software. The IntelliSpace Portal is a multimodality thin-client applications server that delivers diagnostic viewing and clinical applications, while the Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation.

The recall was initiated because the software may produce significantly different results in the colors and size of the affected area when customers use the "Time Sensitive" and "Time Insensitive" methods. This discrepancy could impact the consistency of diagnostic viewing.

The affected units were distributed worldwide, including in the United States (specifically Arizona, Oregon, Pennsylvania, and Texas) and in Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, and the United Kingdom. The recall involves specific model numbers 881001 and 728260 with listed serial numbers. Users should contact Philips Medical Systems for further instructions on resolving the software discrepancy.

The recalled product

Product: IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is…
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Software
Hazard: software-defect
inconsistent-results
Affected units: 38

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: 85104
80818
85088
82038
81013
80911
82017
80994
81021
81017
81065
81161
81164
81130
81004
81003 & 80979. Model number: 728260
serial numbers: 10102
6483
14691

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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