Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging System.
FDA device recall Z-0621-2010 · posted 2010-01-13 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. This issue could lead to a patient fall if the unintended motion occurs during patient
- Action taken
- Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 21
- Distribution
- Worldwide distribution: USA, SRI LANKA, ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, BELARUS, BELGIUM, BOLIVIA, BOSNIA & Herzegovina, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBL
- Date initiated
- 2009-12-22
- Date posted
- 2010-01-13
- Date terminated
- 2015-11-13
- 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 |