FDA Medical Device Recalls (openFDA)
GE Vingmed Ultrasound As: GE Healthcare Vivid S60N, ultrasound device
- Recall number
- Z-2126-2023
- Recalling firm
- GE Vingmed Ultrasound As
- Product
- GE Healthcare Vivid S60N, ultrasound device
- Status
- Open, Classified
- Initiated
- 2023-05-30
- Posted
- 2023-07-10
- Terminated
- not on file
- Reason
- 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
- 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.
- Quantity
- not on file
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- Software versions: v203, v204, v205, v206
- 510(k) numbers
- ["K170878","K182450","K200497","K211216","K220619","K223832"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3002808457
- Firm city
- Horten
- Firm state
- not on file
- Firm country
- Norway
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