Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system desi
FDA device recall Z-1088-2016 · posted 2016-03-08 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality
- Action taken
- Medtronic Navigation issued a Field Safety Notice dated January 29, 2016, to notify them of a hardware correction in the unit. A Medtronic service representative will service the system and arrange for an inspection of the system. This representative will properly torque the eight (8) screws if they find them to be loose. In the meantime, if noise or vibration are observed during use of the system customers should contact their Medtronic representative to report the issue. Customers with questions were instructed to call 720-890-3160. For questions regarding this recall call 978-698-6000.
- Root cause
- Process control
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 1 unit
- Distribution
- Worldwide Distribution to Austria only.
- Date initiated
- 2016-01-29
- Date posted
- 2016-03-08
- Date terminated
- 2016-03-10
- 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 |