FDA Device recall Z-1538-2012
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
- FDA Device
- Class II
- terminated
- Published 2012-06-20
On 2012-06-20 the FDA classified a Class II recall of Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide by Philips Healthcare, citing 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. .W….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1538-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-10-19 |
| Published | 2012-06-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Healthcare |
| Distribution | US |
Product
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
Reason
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
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-1538-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.