SIGNA Pioneer nuclear magnetic resonance imaging system
FDA device recall Z-0134-2022 · posted 2021-10-16 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- Action taken
- GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 5 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, Germa
- Date initiated
- 2021-08-26
- Date posted
- 2021-10-16
- Date terminated
- 2026-05-04
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIGNAPioneer (K160621) | GE Healthcare | 2016-03-29 |
| SIGNA Pioneer (K153003) | GE Healthcare | 2015-10-27 |
| SIGNA Pioneer (K143345) | Ge Healthcare Japan Corporation | 2015-07-10 |