FDA Device recall Z-1818-2012
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
- FDA Device
- Class II
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class II recall of Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system by Philips Healthcare, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1818-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-22 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Healthcare |
| Distribution | US |
Product
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
Reason
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
Identifiers
| code_info | Software release 2.0.2 and 2.0.2SP1 including mirror icon |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1818-2012%22
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