GE Healthcare Recalls ADVANTX LCA Systems Due to CRT Monitor Fall Risk
GE Healthcare is recalling ADVANTX LCA and other systems because aged CRT monitors may fall. The recall covers 1,598 units in the US and internationally.
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 structural defect (falling monitors) that poses a risk of significant injury, meeting the criteria for a Severe rating.
Plain-English summary
GE Healthcare, LLC is conducting a Class II recall of ADVANTX LCA and other medical imaging systems, including Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, and Innova 2000. The recall is due to the potential for aged CRT monitors to fall.
A total of 1,598 units are affected, with 824 units in the United States and 774 units outside the US. The affected units were distributed across numerous US states and international locations, including Canada, the United Kingdom, and Germany. Specific lot and serial numbers are listed in the recall documentation.
This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences. Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the potential hazard.
The recalled product
- Product
- ADVANTX LCA
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Imaging Systems
Distribution
Part of a larger recall action
This product is one of 13 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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