GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular).
FDA device recall Z-1043-2007 · posted 2007-07-10 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- Reason for recall
- Caution on the non-detection of small invasive objects/devices, which project out from the skin surfaces (e.g. biopsy or other needles) while using the Innova Sense software option designed for patient contouring. Usage of Innova Sense patient contouring for such devices could potentially lead to patient injury.
- Action taken
- A "GE Healthcare Urgent: Safety Notice" dated January 24, 2007 was sent to consignees describing the product, problem, safety instructions, product correction and contact information.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 205
- Distribution
- Worldwide, including USA, Guam, Canada, Australia, China, India, Japan, Korea, Malaysia, New Zealand, Algeria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Jordan, Morocc
- Date initiated
- 2007-03-26
- Date posted
- 2007-07-10
- Date terminated
- 2008-10-21
- Location
- Waukesha, WI
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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 |