GE Healthcare Recalls Two Ultrasound Systems Due to Transducer Misalignment
GE Healthcare is recalling two ultrasound systems because transvaginal probes may be misaligned. The devices were distributed 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 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 (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling two ultrasound systems, specifically the Repair RIC5-9A-RS System and the Refurbish RIC-5-9-D REALTIME 4D. The recall is due to a potential for transducer mis-alignment in certain transvaginal probes.
The affected devices were distributed in the United States to Texas, as well as internationally to France, Greece, and Switzerland. The specific units are identified by Model H48701EJ (Serial Number 205375KR9) and Model KTZ157043-R (Serial Number 152323KR2).
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Ultrasound
- Hazard
- Affected units
- 2
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)
- Model H48701EJ
- Serial Number 205375KR9
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 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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