GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System)
FDA device recall Z-0870-2007 · posted 2007-06-05 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- Reason for recall
- Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control room) or in-room InnovaCentral/Touch-Screen
- Action taken
- A letter dated Jan. 18, 2007, was sent to consignees describing the problem, product ,safety instructions and contact information. Software upgrades were promised for correction.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 39
- Distribution
- Worldwide Distribution: USA states including-AZ,CA,CO,DE,FL,GA,IL,IN, MD,MN,MO,NJ,NV,NY,OH,OK,OR,PA,SC,SD,TX, UT, VA,WA,WI, and countries of Canada, Belgium, China, Czech Republic, Finland, France, Ge
- Date initiated
- 2007-03-26
- Date posted
- 2007-06-05
- Date terminated
- 2008-10-21
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 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 2100 (K050489) | Ge Medical Systems, LLC | 2005-03-11 |
| INNOVA 4100, INNOVA 3100 (K042053) | Ge Medical Systems, Inc. | 2004-08-26 |
| INNOVA 3100 (K031637) | GE Medical Systems | 2003-08-22 |
| INNOVA 4100 (K023178) | Ge Medical Systems, Inc. | 2002-11-26 |