Z-1965-2019Class II

Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D

Name: Z-1965-2019 Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Creator: GE Healthcare, LLC
Published: 2019-07-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-07-02 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D on 2019-07-02. FDA classified it as Class II and gives the reason as "Potential for a transducer mis-alignment in certain transvaginal probes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1965-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-02
Posted: 2019-07-12
Terminated: 2020-10-05
Recalling firm: GE Healthcare
Product: Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Potential for a transducer mis-alignment in certain transvaginal probes.
Root cause tag: design
FDA 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 in commerce: 2 devices
Distribution: Distribution in the US to Texas. International distribution to France, Greece and Switzerland.
Product codes and lots: Model H48701EJ; Serial Number 205375KR9; (UDI Number) 01008406821085531116071121205375KR9. Model KTZ157043-R Serial Number 152323KR2 (UDI Number Not Available)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1965-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1964-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12
Z-1965-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12

Product code IYN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)