Medtronic Recalls O-arm O2 Imaging Systems Due to Belt Loosening
Medtronic is recalling 90 O-arm O2 Imaging Systems because a manufacturing issue may cause the gantry tractor motor drive belt to loosen, potentially rotating 3D images relative to the patient's physical position.
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 the hazard involves a risk of harm (misregistration of images relative to patient position) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic Navigation, Inc. is recalling 90 units of the O-arm O2 Imaging System (Product Number/CFN: BI-700-02000) due to a manufacturing issue. The affected systems were distributed in the United States and several international countries, including Australia, Canada, China, France, Germany, India, Italy, Japan, Lebanon, Netherlands, Romania, Saudi Arabia, Spain, Sweden, Switzerland, and the United Kingdom.
The recall is necessary because the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency than expected. If the belt loosens, it may result in the rotation of 3D images about the gantry isocenter. While the 3D image remains anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.
Specific serial numbers and Unique Device Identifiers (UDIs) for the affected units are listed in the official recall documentation. Healthcare providers and facilities should check their inventory against the provided list of serial numbers and UDIs to determine if they possess affected units.
The recalled product
- Product
- O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Category
- Medical Device — Imaging System
- Affected units
- 90
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 (13)
- 00763000132378
- 00763000074128
- 00763000134488 00763000081003
- 00763000074067
- 00763000168605
- 00763000074135
- 00763000134518
- 00763000081041
- 00763000135829
- 00763000081102
- 00763000074050
- 00763000074098
- 00763000135836
Distribution
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