GE Healthcare Recalls Senographe Essential Mammography Systems Due to Manual Defect
GE Healthcare is recalling 49 Senographe Essential mammography systems because a defective CD makes the operator manual inaccessible.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to inaccessible documentation (Operator Manual CD) with no reported injuries or illnesses, fitting the criteria for a moderate severity issue.
Plain-English summary
GE Healthcare, LLC is recalling 49 Senographe Essential mammography systems installed in the United States. The recall is due to a defective Operator Manual CD that renders the associated Operator Instructions inaccessible.
The affected systems are used for screening and diagnosing breast cancer. The specific models involved are 5144816-10 rev 2, 3 or 6 and 5144816-10-LE rev1. The devices were distributed nationwide, including in New Jersey, Colorado, Louisiana, Alabama, Ohio, Massachusetts, North Carolina, Maine, Wisconsin, Georgia, Pennsylvania, Texas, Indiana, New York, Missouri, Kentucky, Kansas, California, Minnesota, Florida, and Illinois.
This recall is classified as Class II by the FDA. Users should contact GE Healthcare for further instructions regarding the defective CD.
The recalled product
- Product
- GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional…
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 49
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 (2)
- Models 5144816-10 rev 2
- 3 or 6 and 5144816-10-LE rev1.
Distribution
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