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Terminated

Allura Xper FD 10 x-ray, angiographic system

FDA Recall Z-0162-2007 · Posted 2006-11-08

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeIZI
Date Initiated2006-08-24
Date Terminated2008-05-29
Product Quantity90 total devices - FD 10/10 & FD 10

Reason for Recall

Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned.

Firm Action

A letter dated September 1, 2006 was sent to customers on September 5, 2006. The letter advised customers of the problem and advised a service representative will visit the consignee to install a new software upgrade.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041949ALLURA XPER FD10Philips Medical Systems North America Co. · 2004-07-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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