FDA Medical Device Recalls (openFDA)
GE Medical Systems SCS: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
- Recall number
- Z-2553-2026
- Recalling firm
- GE Medical Systems SCS
- Product
- GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
- Status
- Open, Classified
- Initiated
- 2026-05-08
- Posted
- 2026-06-24
- Terminated
- not on file
- Reason
- GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.
- Root cause
- Software design
- Action
- GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 5/8/2026 by letter delivered via traceable means. The notice explained the issue, potential risk to patient, and requested the following: "Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use the device by following the instructions below: " Ensure that users verify the correct patient identity (including name, patient ID, and date of birth) and confirm that the selected study matches the intended patient and clinical context prior to reviewing or interpreting imaging studies. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via this FMI 80193 Digital CRF or print, fill out manually, scan, and email to Recall.80193@gehealthcare.com." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
- Quantity
- 340 servers
- Distribution
- Worldwide distribution - United States Nationwide and the countries of Algeria, Australia, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Morocco, Nepal, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, United Arab Emirates, United Kingdom, Vietnam.
- Lot, serial or model codes
- REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
- 510(k) numbers
- K081985
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000284313
- Firm city
- Buc
- Firm state
- not on file
- Firm country
- France
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