GE Healthcare 2023-11-01 Health serious FDA
Health · FDA · Recall #FDA-Z-0139-2024
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation;… Recall
Issued November 1, 2023 · GE Healthcare
In November 2023, GE Healthcare recalled the Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation;…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
What you should do
- 1 Stop using Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation;… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GE Healthcare to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- GE Healthcare
- Category
- Health
- Recall date
- November 1, 2023
- Units affected
- Not reported
- Sold at
- US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysi
- Recall number
- FDA-Z-0139-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- GE Healthcare has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.