Recall Z-0935-2013— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2011-05-10, terminated 2016-06-30. It names 5 FDA 510(k) clearances: K091536, K083147, K081028 and 2 more. Product: Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.. Reason: An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-05-10
- Terminated
- 2016-06-30
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
5 on FDA's record- K091536 — OPTIMA MR450W
- K083147 — DISCOVERY MR450
- K081028 — SIGNA 3.0T MR750 SYSTEM
- K052978 — GE 1.5T SIGNA HDE MR SYSTEM
- K052293 — GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.
Reason for recall
An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.
Data sourced from openFDA. This site is unofficial and independent of the FDA.