Innova 2100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic images of human anatomy for
FDA device recall Z-1921-2010 · posted 2010-06-29 · Terminated
Recall details
- Recalling firm
- Ge Healthcare, Llc
- Reason for recall
- GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety.
- Action taken
- Consignees were sent on 6/3/10 a GE Healthcare "Urgent Medical device Correction" letter dated May 12, 2010. The letter was addressed to Hospital Administrators/ Risk Mangers, Managers of Radiology/Cardiology and Radiologists/ Cardiologists. The letter included the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. Customers are to contact a service representative immediately if they notice any cable damage.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 10
- Distribution
- Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDE
- Date initiated
- 2010-06-03
- Date posted
- 2010-06-29
- Date terminated
- 2015-09-28
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVA 2100 (K050489) | Ge Medical Systems, LLC | 2005-03-11 |
| INNOVA 4100, INNOVA 3100 (K042053) | Ge Medical Systems, Inc. | 2004-08-26 |
| DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION (K033244) | Ge Medical Systems, Inc. | 2003-10-16 |
| INNOVA 3100 (K031637) | GE Medical Systems | 2003-08-22 |
| INNOVA 4100 (K023178) | Ge Medical Systems, Inc. | 2002-11-26 |