Philips Digital Diagnost Software Version R2 — Class II medical device recall Z-0475-2013
Terminated recall by Philips Healthcare Inc., reported 2012-12-12, distributed nationwide. With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower rig
| Recall number | Z-0475-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2012-10-30 |
| Classified | 2012-12-04 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2017-01-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CL, CZ, DE, DK, EE, EG, ES, FI, FR, GB, HR, ID, IN, IQ, IT, JP, KR, LT, LV, MT, MX, NL, NO, NZ, OM, PL, PT, QA, RO, RU, SA, SE, SG, SK, TR, TW, ZA |
| Quantity | 623 units |
| Model numbers | 712020, 712022 |
Product
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0475-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.