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Terminated

Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021

FDA Recall Z-0329-2008 · Posted 2007-12-07

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeIZI
Date Initiated2007-09-24
Date Terminated2012-05-03
Product Quantity468 units

Reason for Recall

Inaccurate anatomical measurements when using the optional SmartMask feature

Firm Action

The recalling firm sent customers an Urgent Device Correction notification letter dated 09/21/07 via certified mail - return receipt requested. This notification provided a short term work around for the device defect. For a permanent fix, the recalling firm is developing software update to check for mismatch at the start of a subtracted fluoroscopy run, and will contact customers to schedule an install. Installation is expected to begin 10/2007 and be completed 06/2008.

Root Cause

Device Design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033737ALLURA XPER FD20Philips Medical Systems North America, Inc. · 2003-12-09

Official Source

View FDA Recall →

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

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