Innova 3100/3100IQ is a cardiovascular Imaging System. The system consists of an a monoplane positioner, a vascular or c
FDA device recall Z-2040-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system
- Action taken
- Consignees were contacted by means of a Urgent Medical Device Correction letter dated 1/14/07. The letter is addressed to; Hospital Administrator, Hospital Risk Management Department, Manger of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the affected product and safety issue. The letter offers recommendations, solutions and provides contact information. If you have questions contact the firm: In the US contact the call center at 800-437-1171, option 4 and other countries should contact your local GE Healthcare field service representative.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 410
- Distribution
- USA: AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, OH OR, PA, SC, TN, TX, WI, AK, AL, AR, AZ, CT, DE, GA, HI, IA, ID, KS, KY,LA ME, MI, MN, MS, MT, ND, NE, NH, NY, OK, RI, UT, VA, WA, WI
- Date initiated
- 2008-01-14
- Date posted
- 2008-09-16
- Date terminated
- 2011-12-17
- 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 |
| INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ (K052412) | GE Healthcare | 2005-09-16 |
| INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ (K052157) | Ge Medical Systems, LLC | 2005-08-25 |
| INNOVA 3100 (K031637) | GE Medical Systems | 2003-08-22 |