Repair RIC5-9A-RS System, imaging, pulsed doppler… recallZ-1965-2019 · GE Healthcare, LLC · initiated Jul 2, 2019
Class II Terminated All recalls posted in July 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for a transducer mis-alignment in certain transvaginal probes.
FDA root cause category: Device Design
What the company is doing
GE Healthcare notified customers on about 07/02/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that they could continue to use the affected probes, but prior to performing a biopsy, customers should make sure they follow the instructions for safe use in the Basic User Manual to ensure proper device alignment, specifically including the biopsy, biopsy safety and biopsy setup sections. GE Healthcare will correct all affected devices at no cost and a GE Healthcare representative will contact customers to arrange for the correction. Customers were also instructed to complete and return the Medical Device Notification Acknowledgement Response form. Questions or concerns regarding the notification can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall details
- Recall number
- Z-1965-2019
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 2, 2019
- Posted by the FDA
- Jul 12, 2019
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 2 devices
- Product code
- IYN
- FDA submissions
- K180374, K180535, K181783
- Distribution
- Distribution in the US to Texas. International distribution to France, Greece and Switzerland.
Product description
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Code information (models, lots, serial numbers)
Model H48701EJ; Serial Number 205375KR9; (UDI Number) 01008406821085531116071121205375KR9. Model KTZ157043-R Serial Number 152323KR2 (UDI Number Not Available)
Other devices under the same FDA submission
2 devices cleared under K180374, K180535, K181783 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA IC9-RSGE Healthcare Austria GmbH & Co OG · System, imaging, pulsed echo, ultrasonic55 reports
- VOLUSON S10 Expert BT18GE Ultrasound Korea Ltd. · Transducer, ultrasonic, diagnostic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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