The Recall Desk
HighFDA (Devices)·Z-2244-2012·Announced 2012-08-29

Medtronic O-arm Imaging System Recalled for High Voltage Relay Overheating

Medtronic is recalling 17 O-arm Imaging Systems because a high voltage relay fault may cause overheating and burning.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of fire/burn injury from overheating, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Navigation, Inc. is recalling 17 units of the Medtronic O-arm Imaging System. The affected product numbers are BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, and BI-700-00027-230R. The specific serial numbers affected are 109R, 118R, 124, 136, 159, 170, 218, 222, 223, 236, 239, 299, 309R, 402, 410, 412, and 414.

The recall was initiated because a fault in a high voltage relay within the system might cause the relay to overheat and burn. This is classified as a Class II recall by the U.S. Food and Drug Administration.

The affected units were distributed worldwide, including in the United States (specifically in the states of AL, CO, FL, IA, MI, NC, NE, and NY) and in the countries of South Africa, Italy, and Spain. Users of these devices should contact Medtronic Navigation, Inc. for further instructions regarding the recall.

The recalled product

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, BI-700-00027-230R.
Manufacturer
Medtronic Navigation, Inc.
Category
Medical Device — Imaging System
Hazard
Affected units
17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • Serial Numbers: 109R
  • 118R
  • 124
  • 136
  • 159
  • 170
  • 218
  • 222
  • 223
  • 236
  • 239
  • 299
  • 309R
  • 402
  • 410
  • 412
  • 414.

Distribution

Distributed in 8 states:

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