Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic sys
FDA device recall Z-1818-2012 · posted 2012-06-15 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- With Digital Diagnost (DIDI) R 2.0.2 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 issued a Field Safety Notice on 5/22/12 advising users of the error. A software update (Rel 2.1.2) will issue to correct the problem. Contact your local Philips representative. 1-800-722-9377. For questions regarding this recall call 978-687-1501.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 752 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Canada AFGHANISTAN ALBANIA ALGERIA ANGOLA ARGENTINA ARMENIA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BAHRAIN BANGL
- Date initiated
- 2012-05-22
- Date posted
- 2012-06-15
- Date terminated
- 2017-02-24
- 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 |