GE Healthcare Recalls Three Ultrasound Probes Due to Transducer Misalignment
GE Healthcare is recalling three refurbished RIC5-9-D ultrasound probes due to a potential transducer misalignment hazard.
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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling three refurbished RIC5-9-D ROHS compliant ultrasound probes. The recall is due to a potential for transducer misalignment in certain transvaginal probes.
The affected devices were distributed in the United States to Texas and internationally to France, Greece, and Switzerland. Specific serial numbers and UDI numbers for the three devices are listed in the official recall record.
Consumers and healthcare facilities should stop using the affected devices and contact GE Healthcare for further instructions or a replacement.
The recalled product
- Product
- Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 3
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 (3)
- 198026KR7 (Not Available)
- 220616KR7 (01008406821084301117091521220616KR7)
- 205375KR9 (01008406821085531116071121205375KR9)
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.
See all 2 products in this recall →Related recalls
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