Medtronic O-arm¿ Imaging System. Product Numbers recall
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…
Why was Medtronic O-arm¿ Imaging System. Product Numbers recalled?
A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.
- Product
- 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…
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 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.
- Recall date
- August 29, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)