GE Healthcare Recalls PET VCAR Software Due to Calculation Error
GE Healthcare is recalling PET VCAR software due to a potential safety issue with automated PERCIST response criteria calculations.
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 software defect that could impact clinical decision-making (diagnosis/staging), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
GE Healthcare, LLC is recalling the PET VCAR application software installed on specific versions of the Advantage Workstation and AW Server. The recall is due to a potential safety issue identified in the automated PERCIST response criteria calculation applied within the application.
PET VCAR is a PET/CT software package used by clinicians to assist in diagnosis, staging, treatment planning, and monitoring treatment response. The affected software versions include Advantage Workstation 4.6 and AW Server 2.0, specifically those with Volume Share 5 enhanced and specific vxtl versions.
The recall affects 231 units distributed worldwide, including 38 units in the United States and 193 units internationally. GE Healthcare has become aware of this potential safety issue and is taking action to address the calculation error.
The recalled product
- Product
- GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Software
Distribution
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