Philips IntelliSpace PACS 4.4 Software Recall for Image Storage Defect
Philips is recalling IntelliSpace PACS 4.4 software due to a timing issue that may prevent the system from storing additional images, potentially affecting clinical diagnoses.
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 3/5 (High).
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 involves a risk-of-harm product (medical device) where a software defect could lead to incorrect diagnoses, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Healthcare Informatics, Inc. is recalling 71 units of the IntelliSpace PACS 4.4 Image Management System. This software package is used with general-purpose computing hardware to acquire, store, distribute, process, and display medical images and associated data in clinical environments. The affected units were distributed nationwide in the United States and in Canada.
The recall was initiated because Philips identified a software timing issue that may result in the device failing to store additional images received before processing is complete. The source text notes that these missing images may contain pathology, which could result in a different diagnosis if they had been available at the time of interpretation.
The system is intended for use by trained professionals, including physicians, nurses, and medical technicians. No specific instructions for consumers are provided in the source text, as the product is a professional medical device.
The recalled product
- Product
- Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured…
- Manufacturer
- Philips Healthcare Informatics, Inc.
- Category
- Medical Device — Software
- Affected units
- 71
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 (1)
- All units of these IntelliSpace PACS.
Distribution
Distributed nationwide across the United States.
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Similar recalls
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FDA (Devices) · 2014-08-27
- HighPhilips Recalls IntelliSpace PACS 4.4 Due to Potential Image Corruption
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