GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular imaging system). The In
FDA device recall Z-1518-2008 · posted 2008-09-30 · Terminated
Recall details
- Recalling firm
- Datex - Ohmeda, Inc
- Reason for recall
- User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to incorrect overall dose management, resulting in unnecessary exposure and can be a contributing factor for skin injury. The alarm can be heard in the control room.
- Action taken
- GE Field Engineers are visiting all affected customers to apply updated software. For assistance contact Datax-Ohmeda, Inc., at 1-608-221-1551.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 281
- Distribution
- within US: AL, AR, AZ, CA,CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. OUS to include: Alger
- Date initiated
- 2006-08-17
- Date posted
- 2008-09-30
- Date terminated
- 2009-06-09
- Location
- Madison, WI
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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 |