MRP-7000, AIRIS Magnetic Resonance Imaging Systems
This recall has been terminated (originally issued June 10, 2006).
- Recall Initiated
- March 17, 2006
- Posted
- June 10, 2006
- Terminated
- November 13, 2008
- Recall Number
- Z-1105-06
- Quantity
- 283
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis.
Distribution
Nationwide-The devices were distributed to consignees located througout the United States.
Lot / Code Info
Asset Tag Numbers: 7001-7154; A007-A901; AG004-AG039
Root Cause
Other
Action Taken
On 3/17/2006, the firm began conducting a survey of all afftected customer sites in order to determine if corrected software has been installed on the unit(s) at each customer location. If the corrected software has not been installed, the firm''s Field Service Engineers will install software upgrades as necessary.