Medtronic Navigation O-arm 02 surgical x-ray imaging system
Class I - DangerousWhat Should You Do?
- Check if you have this product: model number BT-700-02000
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Navigation, Inc.-Littleton
- Reason for Recall:
- Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Product Codes/Lot Numbers:
model number BT-700-02000
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2083-2016
Related Recalls
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Medtronic Navigation, Inc.-Littleton
Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.
Ground cable installed incorrectly.
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Medtronic Navigation, Inc.-Littleton
Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is 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.