Recall Z-1105-06 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
MRP-7000, AIRIS Magnetic Resonance Imaging Systems
| Date | Jun 10, 2006 (initiated Mar 17, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 283 |
| Distribution | Nationwide-The devices were distributed to consignees located througout the United States. |
| FDA record | Open on fda.gov |