Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital
FDA device recall Z-1195-2009 · posted 2009-05-19 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- GE Healthcare has become aware of a potential image storage failure on Innova 2121 IQ/ 3131 IQ cardiovascular imaging systems that may impact patient safety. This intermittent communication failure on the image storage chain may result in the following situations: Record abort, Record not available, Fluorostore function not available, Review not available, Boot/Reset failure. Fluoroscopy imag
- Action taken
- A GE Healthcare "Urgent Medical Device Correction" letter dated February 2, 2009 was sent to consignees via mail. The letter was directed to Hospital Administrator/Risk Manger, Managers of Radiology/Cardiology and Radiologists/Cardiologists addressing the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Further questions should be addressed to GE Healthcare at 1-800-437-1171.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 85
- Distribution
- Worldwide Distribution -- USA including states of CA, CO, FL, HI, IA, IL, IN, KS, MD, MA, MN, MO, NY, OH, OR, PA, TN, TX, WA, WV, WI and VA and countries of the United Kingdom, Romania, Japan, Taiwan,
- Date initiated
- 2008-11-21
- Date posted
- 2009-05-19
- Date terminated
- 2013-11-21
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT (K061163) | Ge Medical Systems, LLC | 2006-06-07 |
| DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 (K060259) | Ge Medical Systems, LLC | 2006-02-22 |