Philips Digital Diagnost Software Recall for Image Marker Error
Philips Healthcare Inc. is recalling Digital Diagnost Software releases 2.0.2 and 2.0.2SP1 because a mirrored image marker can be mistaken for a right-side patient indicator.
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 imaging software) where a mislabeled marker could lead to diagnostic errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Healthcare Inc. is recalling 752 units of Digital Diagnost Software, specifically releases 2.0.2 and 2.0.2SP1, used with stationary fluoroscopic systems. The recall is due to a software defect where a mirrored "R in a circle" icon appears in the lower left corner of images after they are mirrored back in the PACS system.
This visual artifact can be mistaken for a "right patient side" marker, even when the image actually represents the left patient side. This misidentification could lead to incorrect clinical interpretation of the medical images.
The affected software was distributed worldwide, including in the United States and numerous foreign countries. Healthcare facilities using this specific software version should contact Philips Healthcare Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 752
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)
- Software release 2.0.2 and 2.0.2SP1 including mirror icon
Distribution
Distributed nationwide across the United States.
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