GE Healthcare, LLC Recall 88665
Description: SIGNA Pioneer nuclear magnetic resonance imaging system
GE Healthcare, LLC Recall 88665 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0134-2022 |
| Event ID | 88665 |
| Event Description | SIGNA Pioneer nuclear magnetic resonance imaging system |
| Product Type | Devices |
| Distribution | Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK |
| Quantity | 5 devices |
| Recall Reason | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| Device Classification | 20211027 |
| Device Code Info | Software version PX29.1; and PX25.4 (T), PX28.3 (China only) |
| Center Classification Date | 20211016 |
| Recall Initiation Date | 20210826 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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