Drug recall
1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The…
FDA recall event 77488 · Class II · GE Medical Systems, LLC
Key facts
| Event ID | 77488 |
|---|---|
| Recall numbers | Z-3021-2017, Z-3022-2017, Z-3023-2017, Z-3024-2017, Z-3025-2017, Z-3026-2017, Z-3027-2017, Z-3028-2017, Z-3029-2017 |
| Recalling firm | GE Medical Systems, LLC |
| Product type | Devices |
| Products | 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole body magnetic resonance scanner designed to support…, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high…, Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times…, Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short…, Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan… and 4 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. |
| Initiation date | May 11, 2017 |
| Report date | Aug 23, 2017 |
| Termination date | Sep 9, 2020 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 2183553 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: