Philips Healthcare Practix Convenio Mobile X-ray system Worldwide… — Class II medical device recall Z-1538-2012
Terminated recall by Philips Healthcare Inc., reported 2012-06-20, distributed nationwide. When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch of
| Recall number | Z-1538-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2011-10-19 |
| Classified | 2012-06-13 |
| Reported by FDA | 2012-06-20 |
| Terminated | 2017-01-18 |
| Distributed | Nationwide (US) |
| Quantity | 11 |
Product
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
Reason for recall
When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when component supplie
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-1538-2012. 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.