Philips Digital Diagnost Stationary radiographic system — Class II medical device recall Z-0900-2013
Terminated recall by Philips Healthcare Inc., reported 2013-03-13, distributed nationwide. When the operator for a wall stand view selects an "image rotation" different from default, or such image rota
| Recall number | Z-0900-2013 |
|---|---|
| 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 | 2013-03-01 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2013-07-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, CA, CL, CZ, DE, EE, ES, FR, GB, HU, IE, IT, JP, KR, MX, NL, NO, NZ, OM, PA, PE, PL, QA, RU, SA, SE, TH, ZA |
| Quantity | 360 |
Product
Philips Digital Diagnost Stationary radiographic system
Reason for recall
When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
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-0900-2013. 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.