FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
- Recall number
- Z-1964-2019
- Recalling firm
- GE Healthcare, LLC
- Product
- Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
- Status
- Terminated
- Initiated
- 2019-07-02
- Posted
- 2019-07-12
- Terminated
- 2020-10-05
- Reason
- Potential for a transducer mis-alignment in certain transvaginal probes.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 3 devices
- Distribution
- Distribution in the US to Texas. International distribution to France, Greece and Switzerland.
- Lot, serial or model codes
- Model KTZ303987-R - Serial Number (UDI Number): 226914KR0 (01008406821084301118032721226914KR0), 198026KR7 (Not Available), 220616KR7 (01008406821084301117091521220616KR7), 205375KR9 (01008406821085531116071121205375KR9)
- 510(k) numbers
- ["K152309","K160182","K170445","K173555","K181985"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28