Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Reported: August 29, 2012 Initiated: July 11, 2012 #Z-2244-2012
Product Description
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Reason for Recall
A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
Details
- Recalling Firm
- Medtronic Navigation, Inc.
- Units Affected
- 17 units
- Distribution
- Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.
- Location
- Littleton, MA
Frequently Asked Questions
What product was recalled? ▼
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.. Recalled by Medtronic Navigation, Inc.. Units affected: 17 units.
Why was this product recalled? ▼
A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2012. Severity: Moderate. Recall number: Z-2244-2012.
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