Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue. |
| Product | GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device. |
| Quantity | 383 (US = 24;OUS = 359) |
| Distribution | US: AZ, CA, CT, FL, IL, MA, MS, MO, NC, PR, TX, WI. OUS: Algeria, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican republic, Egypt, France, Germany, Ghana, Guatemala, HONG KONG, Hungary, India, Indonesia, Iran, Italy, Jamaica, Japan, Korea, Kuwait, LEBANON, Lithuania, Maldives, Martinique, Mexico, MOROCCO, Netherlands, New Zealand, OMAN, Pakistan, Philippines, Poland, Portuga… |
| Initiated | 2016-08-31 |
| Classified | 2016-09-02 |
| Terminated | 2018-07-31 |
| Recall number | Z-2731-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-2731-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75081/
Alerts for GE HealthCare Technologies Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.