GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System The product is used as a diagnostic imaging device to pro
FDA device recall Z-1891-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.
- Action taken
- Consignees were sent a "GE Healthcare Product Safety Notification" letter dated 9/14/07. The letter was addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the safety issue, affected product, safety instructions, product correction and contact information. FMI 60745 and 60746 was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. For assistance, contact GE Healthcare at 1-262-544-3894.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 147
- Distribution
- AL, CA, CO,CT, AZ, FL, GA, LA, MS, MT, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NY, NV, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PUERTO RICO. AUSTRALIA, CHINA, HONG KONG, INDIA, JAPAN, S
- Date initiated
- 2007-12-14
- Date posted
- 2008-09-17
- Date terminated
- 2012-04-12
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM (K041476) | Ge Medical Systems, LLC | 2004-06-17 |