Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surg
FDA device recall Z-0070-2017 · posted 2016-10-11 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.-Littleton
- Reason for recall
- O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
- Action taken
- Medtronic Navigation contacted customers via telephone beginning September 23, 2016. Customers were informed of the affected product, problem and actions to be taken. Medtronic requests that users immediately discontinue the use of the O-Arm O2 Surgical Imaging system for automatic registration in Stealth Station navigated surgical procedures until further notice. Medtronic Service personnel have been scheduled to begin the necessary inspections and re-calibration activities on customer systems beginning on September 23, 2016.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 14 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
- Date initiated
- 2016-09-22
- Date posted
- 2016-10-11
- Date terminated
- 2017-05-12
- Location
- Littleton, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| O-Arm O2 Imaging System (K151000) | Medtronic, Inc. | 2015-08-06 |