Skip to content
Recall Observatory FDA recall evidence

Device product

Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide

Z-1538-2012

October 19, 2011

Class II

Product summary

Firm
Philips Healthcare Inc.
Event
Event 61830
Status
Terminated
Classification
Class II
Quantity
11 - US
Official record key
device-enforcement:Z-1538-2012

Official wording

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

Code information: Unavailable

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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