Philips MDC PACS and IntelliSpace PACS DCX Software Recall for Density Errors
Philips is recalling MDC PACS and IntelliSpace PACS DCX software because it may display incorrect density measurements on Enhanced CT and MR examinations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are assigned a score of 3 (High), as they represent a risk of harm where injury has not yet been reported.
Plain-English summary
Philips Medical Systems, Inc. is recalling 373 units of MDC PACS Release R2.x and IntelliSpace PACS DCX R3.x software. This software application is used by trained medical professionals to receive, manage, archive, distribute, and record medical images onto portable digital media. The specific versions affected are MDC PACS R2.2 and R2.3, and IntelliSpace PACS DCX R3.1.
The recall is issued because the software may display incorrect density measurements on Enhanced CT and MR examinations. The agency has classified this recall as Class II, indicating a situation where use of the product could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected software was distributed worldwide, including in the United States (specifically Puerto Rico and the states of CA, FL, IL, NJ, OK, and WA) and numerous international locations. Users of this software should contact Philips Medical Systems, Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliS
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 373
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 Versions: MDC PACS R2.2
- R2.3 IntelliSpace PACS DCX R3.1
Distribution
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