MRP-7000, AIRIS Magnetic Resonance Imaging Systems
FDA device recall Z-1105-06 · posted 2006-06-10 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 283
- Distribution
- Nationwide-The devices were distributed to consignees located througout the United States.
- Date initiated
- 2006-03-17
- Date posted
- 2006-06-10
- Date terminated
- 2008-11-13
- Location
- Twinsburg, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AIRIS (K945155) | Hitachi Medical Systems America, Inc. | 1995-05-24 |
| HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE (K911667) | Hitachi Medical Systems America, Inc. | 1991-05-30 |