Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.
FDA device recall Z-0138-2010 · posted 2009-11-09 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra
- Action taken
- Consignees were sent on May 1, 2009 a GE Healthcare " Urgent Medical Device Correction" letter dated April 16, 2009. The letter was addressed to Hospital Administrator/ Risk Manger, Mangers of Radiology/ Cardiology, and Radiologists/ Cardiologists. The letter described the problem, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 15 AND 46 UNLOCATED
- Distribution
- Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, PO
- Date initiated
- 2009-04-16
- Date posted
- 2009-11-09
- Date terminated
- 2015-12-03
- 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 |