OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
Reported: July 4, 2012 Initiated: November 20, 2006 #Z-1865-2012
Product Description
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
Reason for Recall
Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot.
Details
- Recalling Firm
- GE OEC Medical Systems, Inc
- Units Affected
- 717 units
- Distribution
- Worldwide Distribution.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.. Recalled by GE OEC Medical Systems, Inc. Units affected: 717 units.
Why was this product recalled? ▼
Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 4, 2012. Severity: Moderate. Recall number: Z-1865-2012.
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