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

FDA device recall Z-1538-2012 · posted 2012-06-13 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

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

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

IZL

Quantity affected

11 - US

Distribution

Nationwide Distribution

Date initiated

2011-10-19

Date posted

2012-06-13

Date terminated

2017-01-18

Location

Andover, MA