General X-Ray System types with Digital Spot Imaging (DSI) software
FDA device recall Z-2160-2008 · posted 2008-08-25 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted).
- Action taken
- On 5/20/08 the firm issued an URGENT - DEVICE CORRECTION letter to the consignees advising of the problem, requesting consignees to check the stored or printed images to ensure that it represents the data and images captured from the examination. The firm will issue a Field Change Order to their service representatives providing new software, when software is available. This should be issued by the end of June.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZJ
- Quantity affected
- 41 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-05-23
- Date posted
- 2008-08-25
- Date terminated
- 2010-09-28
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS DSI SYSTEM RELEASE 3.2 (K920793) | Philips Medical Systems, Inc. | 1992-07-17 |