Z-2126-2023Class II

GE Healthcare Vivid S60N, ultrasound device

Name: Z-2126-2023 GE Healthcare Vivid S60N, ultrasound device
Creator: GE Vingmed Ultrasound As
Published: 2023-05-30
License: https://open.fda.gov/license/

GE Vingmed Ultrasound AS / initiated 2023-05-30 / Open, Classified / root cause: manufacturing process

FDA source

GE Vingmed Ultrasound As began a recall of GE Healthcare Vivid S60N, ultrasound device on 2023-05-30. FDA classified it as Class II and gives the reason as "GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2126-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-30
Posted: 2023-07-10
Recalling firm: GE Vingmed Ultrasound AS
Product: GE Healthcare Vivid S60N, ultrasound device
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: GE Healthcare sent an Urgent Medical Device Correction notice to its consignees on 05/30/2023 by mail (traceable means). The notice explained the problem with the instrument and provided the following: "You can continue to use your device. Please follow clinical practice guidelines, which include having a backup imaging plan when performing time-critical examinations or image-guided interventions." The devices will be corrected at no charge to the consignee.
Distribution: Worldwide distribution.
Product codes and lots: Software versions: v203, v204, v205, v206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2126-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2124-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-10
Z-2125-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-10
Z-2126-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-10
Z-2127-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-10

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)