Philips DigitalDiagnost Systems with M Cabinet Model: 712025… — Class II medical device recall Z-2384-2012
Terminated recall by Philips Healthcare Inc., reported 2012-09-26, distributed in OH, WA. Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) Internat
| Recall number | Z-2384-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2012-08-14 |
| Classified | 2012-09-14 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2017-01-17 |
| Distributed | OH, WA |
| Countries outside the US | CA |
| Quantity | 4 systems |
| Serial numbers | 11-K0003, 12-B0001, 12-B0002, 12-B0003 |
| Model numbers | 712025 |
Product
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Reason for recall
Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.
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-2384-2012. 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.