Philips Healthcare Practix Convenio 의 리콜

Recall

61830

Class 2

Z-1538-2012

2011-10-19

2012-06-13

Terminated

United States

2017-01-18

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109197

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.

Philips Healthcare sent a proprosed corrective action letter dated May 3, 2012, to FDA. The proposed corrective action plan is to bring the product into compliance with regulatory requirements by issuing a field corrective action which should be completed by Philips by August 1, 2012. For questions regarding this recall call 978-687-1501.