GE Healthcare Recalls Innova 2000 Systems Due to Monitor Fall Risk
GE Healthcare is recalling Innova 2000 and other systems because aged CRT monitors may fall. The recall covers 1,598 units in the US and abroad.
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 risk-of-harm product (falling monitors) where injury has not yet been reported, which corresponds to a High severity score of 3.
Plain-English summary
GE Healthcare, LLC is conducting a recall of Innova 2000 systems, along with Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, and ADVANTX systems. The recall is due to the potential for aged CRT monitors to fall.
A total of 1,598 units are affected, with 824 located in the United States and 774 outside the US. The distribution includes numerous US states and various international locations. Specific serial numbers and system IDs for the affected units are listed in the official recall documentation.
Healthcare facilities should contact GE Healthcare for instructions on how to address the potential hazard. The source text does not report any injuries or illnesses associated with this recall.
The recalled product
- Product
- Innova 2000
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Imaging Systems
- Hazard
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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