GE Healthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System)
FDA device recall Z-1521-2008 · posted 2008-09-30 · Terminated
Recall details
- Recalling firm
- Datex - Ohmeda, Inc
- Reason for recall
- GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch control (located in the control room).
- Action taken
- An Urgent Medical Device Correction letter, dated June 2008 was sent to customers The letter described the issue, affected products and provided short term user recommendations. GE developed a new software release that corrects this condition and will launch the corrective action to upgrade all affected systems.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 107
- Distribution
- Worldwide Distribution - AL, AZ, CA, FL,, GA, HI, IA,IL, IN, KY, LA,MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV, Puerto Rico. OUS to include: Australia, Byel
- Date initiated
- 2008-05-19
- Date posted
- 2008-09-30
- Date terminated
- 2016-06-30
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVA 4100, INNOVA 3100 (K042053) | Ge Medical Systems, Inc. | 2004-08-26 |
| INNOVA 3100 (K031637) | GE Medical Systems | 2003-08-22 |