Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View softwa
FDA device recall Z-0325-2016 · posted 2015-11-23 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8.
- Action taken
- Philips Healthcare sent an Customer Information Letter dated July 2014, on August 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips will issue a Field Change Order to install updated software in a Service Pack that makes the slice numbering consistent for fused and unfused images. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 307 units
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Denmark Estonia, Ethiopia. France, Germany, Hong Kong, Ind
- Date initiated
- 2014-08-21
- Date posted
- 2015-11-23
- Date terminated
- 2021-05-12
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T (K110151) | Philips Health Care | 2011-03-22 |
| ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 (K063559) | Philips Medical Systems | 2007-01-04 |