Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagn
FDA device recall Z-0475-2013 · posted 2012-12-05 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side.
- Action taken
- Philips Healthcare initiated a recall on October 25, 2012 via Urgent - Field Safety Notice for the Digital Diagnost X-ray System. The letter identified the affected product, problem and actions to be taken. The letter informs customers that Philips will supply a software update kit to version 2.1.4. For questions please contact your local Philips representative 1-800-722-9377.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 623 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, India,
- Date initiated
- 2012-10-30
- Date posted
- 2012-12-05
- Date terminated
- 2017-01-17
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BUCKY VISION (K982795) | Philips Medical Systems, Inc. | 1998-11-24 |