Reported Aug 29, 2012 · Terminated
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120,…
Medtronic Navigation, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 300 Foster St · Littleton, MA · 01460-2017
Is this the product you have?
- Medtronic O-arm¿ Imaging System
- Product Numbers
BI-700-00027-100BI-700-00027-100RBI-700-00027-120BI-700-00027-120RBI-700-00027-230BI-700-00027-230R
- Lot codes and dates
- Serial Numbers
109R118R124136159170218222223236239299309R402410412414
- Serial Numbers
- Amount recalled
- 17 units
Where it was sold
Why it was recalled
A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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