Philips Allura XPER FD 20/10 Angiographic X-ray system. This system with Velara Generator can be identified as type numb

FDA device recall Z-2475-2010 · posted 2010-09-22 · Terminated

Recall details

Recalling firm

Philips Medical Systems North America Co. Phillips

Reason for recall

A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display.

Action taken

The firm, Philips, sent "URGENT-Device Correction" letters dated November 10, 2008, to their customers and informed them about the reliability issue in the Allura XPER and Integris X-ray systems with the High Voltage Velera (HV) Generator. This reliability issue can lead to a system error causing intermittent loss of fluro and/or exposure acquisition, potentially resulting in the loss of the X-ray image on the display. The customers are advised if they experience High Voltage Generator reliability issue and the HV Generator stops working generating an O3EA error, a cold restart is required and reboot the system when the X-Ray image disappears. The firm will implement multiple mandatory Field Change Orders (FCOs) to solve the Generator reliability by updating the software for each X-ray system. The customers could contact Philips Care Center at 800-722-9377, #5, #4, #1 for any questions regarding this recall or 425-487-7469.

Root cause

Other

Status

Terminated

Product code

IZI

Quantity affected

60 units in US

Distribution

Worldwide distribution.

Date initiated

2008-10-23

Date posted

2010-09-22

Date terminated

2011-08-10

Location

Bothell, WA

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