Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Allura Xper FD 10/10 x-ray, angiographic system

FDA Recall Z-0161-2007 · 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.

↑