GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnosti
FDA device recall Z-1100-2013 · posted 2013-04-11 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in frequency encoding direction (including S/I, A/P and R/L) can result in incorrect localization of anatomy and pathological findings.
- Action taken
- GE Healthcare sent an Important Product Information letter dated April 23, 2012. The letter described the Issue, Instructions, Affected Product Details and Product Correction. For questions contact your local service representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 46
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, CO, FL, IL, MD, NJ, NY, OH, OK, TX. and the countries of Australia, Belarus, Canada, France, Germany, India, Japan, Lebanon,
- Date initiated
- 2012-04-23
- Date posted
- 2013-04-11
- Date terminated
- 2014-03-14
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISCOVERY MR750W 3.0T (K103327) | Ge Healthcare Japan Corporation | 2011-09-30 |