Medical Ultrasound Cart Recall: Tilt Mechanism Failure Can Cause Equipment to Fall
GE Venue Go ultrasound carts can develop internal tilt mechanism failure, causing the system to detach from the cart and fall. Some 5,986 devices are affected worldwide.
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: This FDA Class II medical device recall involves a real mechanical failure that presents a risk of harm (equipment falling), with no reported injuries or deaths. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
GE MEDICAL SYSTEMS, ISRAEL LTD. is recalling Venue Go Standard Carts (models H45181VC and H45103VCW) used with Venue Go R2, R3, and R4 ultrasound imaging systems. The carts are distributed worldwide, including throughout the US and its territories.
The recalled carts can develop an internal failure of the vertical and horizontal tilt adjustment mechanism. This mechanical failure can result in the ultrasound imaging system detaching from the cart and falling.
Approximately 5,986 devices are affected by this recall. The carts were manufactured in August 2022 or earlier. Healthcare facilities, imaging centers, military installations, and other providers using these carts should contact GE MEDICAL SYSTEMS for instructions on corrective action or replacement. No injuries have been reported at this time.
The recalled product
- Product
- Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
- Manufacturer
- GE MEDICAL SYSTEMS, ISRAEL LTD.
- Affected units
- 5,986
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 (7)
- Venue Go Standard Carts
- Ref: (H45181VC and H45103VCW) used with Venue Go R2
- R3
- R4 systems R2
- and R4 systems (GTIN 0084068213884
- 00840682190503
- and 00195278516510) that were manufactured 2022-08 and before
Distribution
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