Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Reported: March 20, 2013 Initiated: January 31, 2013 #Z-0926-2013
Product Description
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Reason for Recall
Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
Details
- Recalling Firm
- Medtronic Navigation, Inc.
- Units Affected
- 463 units
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of: Canada, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK,FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN ,KOREA, REPUBLIC OF KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MEXICO, NETHERLANDS, New Zealand, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan(R.O.C.) , THAILAND, TURKEY, UNITED ARAB EMIRATES. and UNITED KINGDOM.
- Location
- Littleton, MA
Frequently Asked Questions
What product was recalled? ▼
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile. Recalled by Medtronic Navigation, Inc.. Units affected: 463 units.
Why was this product recalled? ▼
Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2013. Severity: Moderate. Recall number: Z-0926-2013.
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