GE AdvantageSim MD Software Recall for Incorrect Series Labeling
GE Healthcare is recalling AdvantageSim MD versions 7.4 through 7.6 because incorrect series labeling may lead to under-treatment of tumors.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of under-treatment of a tumor, which constitutes a significant injury risk.
Plain-English summary
GE Healthcare, LLC is recalling 65 units of AdvantageSim MD software, versions 7.4 through 7.6. The affected models are 5160092-2 (Version 7.4), 5160092-3 (Version 7.5), and 5160092-4 (Version 7.6). The software was distributed worldwide, including in the United States and various international locations.
The recall was initiated after a customer reported that when using AdvantageSim MD on an Advantage Workstation, image series could be incorrectly labeled if multiple series with different dates were loaded simultaneously. This mismatch in series labels for structure sets may result in an under-treatment of a tumor due to too small a coverage of the treated volume.
Healthcare facilities and users of the affected software should contact GE Healthcare for instructions on how to resolve the issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Software
- Affected units
- 65
Distribution
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