Philips Easy Diagnost Fluoroscopic System Recalled for Measurement Errors
Philips Healthcare Inc. is recalling six Easy Diagnost stationary fluoroscopic systems because misaligned lead rulers can cause incorrect distance measurements, potentially affecting surgical interventions.
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 medical device where a defect could lead to incorrect surgical interventions, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Philips Healthcare Inc. is recalling six units of the Easy Diagnost stationary fluoroscopic system. The recall affects systems equipped with Eleva software version 4.x and the stitching option. These systems were distributed to six US customers.
The recall is due to a potential measurement error. If a lead ruler is not positioned in the same plane as the anatomical image detail being measured, the resulting distance measurements can be incorrect. Additionally, if the measurement tool is not used to check the ruler or is not used correctly for calibration, this error may not be detected. The source text indicates that as a result, a surgical intervention may be executed based on these incorrect measurements.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any specific injuries or illnesses. Users should refer to the official FDA recall notice for specific instructions on how to address this issue.
The recalled product
- Product
- Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 6
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 systems with Eleva software version 4.x and stitching option.
Distribution
Distribution scope not specified by the agency.
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