GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems. Indicated for use in generating fluoroscop
FDA device recall Z-0540-2010 · posted 2009-12-16 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- GE Healthcare has become aware of a potential limit switch failure with Innova 2121IQ and 3131IQ (Biplane) systems that may impact patient safety. A potential limit switch failure could occur due to collision between the lateral plane of Innova Positioner and other equipment in the room. This collision may break the x-ray and positioning switches, and may not allow exam completion. To date, no in
- Action taken
- GE Healthcare issued an "Urgent Medical Device Correction" notice dated October 14, 2009. The letter was addressed to Hospital Administrators/Risk mangers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact GE Healthcare Systems at 1-800-437-1171, option 4 (U.S.) or contact your local GE Healthcare Service Representative.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 114
- Distribution
- Worldwide Distribution -- Including the UNITED STATES, YEMEN, UNITED KINGDOM, TAIWAN, SINGAPORE, RUSSIA, ROMANIA, MALAYSIA, LYB IA, JAPAN, ITALY, IRELAND, INDONESIA, INDIA, GERMANY, FRANCE, EGYPT, CHI
- Date initiated
- 2009-10-14
- Date posted
- 2009-12-16
- Date terminated
- 2012-02-04
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 (K060259) | Ge Medical Systems, LLC | 2006-02-22 |