Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.
This recall has been terminated (originally issued July 30, 2008).
- Recall Initiated
- January 3, 2008
- Posted
- July 30, 2008
- Terminated
- September 30, 2009
- Recall Number
- Z-1460-2008
- Quantity
- 16 UNITS
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images are imported to a treatment planning system, they may appear with either a mirrored or a rotated view.
Distribution
Worldwide Distribution--USA including states of CA, MA and PA, and countries of UK, Chile, Belgium, Canada and Germany.
Lot / Code Info
Serial Numbers: H770002-H780001, H770012-H780058, H770030-H780034, H770055-H780046, H770068-H780010, H770107-H780050, H770113-H780060, H770119-H780035, H770134-H780026, H770143-H780039, H770159-H780062, H770170-H780056, H770184-H780061, H770212-H780074, H770245-H780086 and H770279-H780105.
Root Cause
Software design
Action Taken
Consignees were notified by an Urgent Medical Device Correction letter issued on 02/05/2008. The letter provided recommended actions for users to follow in order to avoid the software error. The letter informed users that a service pack is being created to correct the issue and that the recalling firm will notify users when it becomes available. For additional information, contact 888-827-4265.