GE Healthcare Recalls LOGIQ e Ultrasound Systems for Patient Data Linking Error
GE Healthcare is recalling 588 LOGIQ e ultrasound systems because image data from one patient may be linked to another patient's ID.
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 involves a data integrity issue (mis-linking of patient data) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving low-risk or theoretical hazards.
Plain-English summary
GE Healthcare, LLC is recalling 588 units of the LOGIQ e Ultrasound System. The recall is due to a potential issue where image data from one patient has the potential to be linked to the patient ID of another patient.
The affected systems are general purpose ultrasound devices intended for use by qualified physicians for evaluation by ultrasound imaging or fluid flow analysis of the human body. The recall covers units distributed worldwide, including the United States and various international markets.
The source text does not specify specific corrective actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this data integrity issue.
The recalled product
- Product
- GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 588
Distribution
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