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Terminated

AD5 table for use with Integris and Integris Allura x-ray systems

FDA Recall Z-0206-06 · Posted 2005-11-29

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeIZI
Date Initiated2005-10-12
Date Terminated2011-03-09
Product Quantity1770 units with AD5 tables

Reason for Recall

Potential for high voltage exposure involving the injector interface connector of patient support tables.

Firm Action

On 10/10/05 the firm issued a letter to customers alerting customers to the problem and advising that the firm will perform an upgrade to the devices at customer sites. In March 2006 the firm issued a second notification letter involving more units.

Root Cause

Other

Distribution Pattern

Devices were distributed nationwide to hospitals/medical centers.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031333PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2Philips Medical Systems North America, Inc. · 2003-05-13K020055PHILIPS INTEGRIS ALLURA 9 WITH FD OPTIONPhilips Medical Systems · 2002-03-15K002016PHILIPS INTEGRIS ALLURAPhilips Medical Systems North America, Inc. · 2000-09-06K984545RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMSPhilips Medical Systems North America, Inc. · 1999-02-25K925302PHILIPS INTEGRIS H/HM SYSTEMPhilips Medical Systems, Inc. · 1992-12-17

Official Source

View FDA Recall →

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

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