Philips Recalls Vereos PET/CT Software Due to Image Errors
Philips Medical Systems is recalling 61 units of Vereos PET/CT software version 2.0.1 due to errors that may produce incorrect images or disrupt procedures.
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 is classified as FDA Class II and involves a risk-of-harm product (medical imaging) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 61 units of the Vereos PET/CT system, specifically software version 2.0.1 (Model Number 882446). The recall is due to software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures. Additionally, the software errors may cause a partial set of images, inability to generate CT or PET images, incorrect scan parameters, or scanning of the incorrect portion of the body.
The affected units were distributed nationwide in the United States. The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 61
Distribution
Distributed nationwide across the United States.
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