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Terminated

AD5 table, modified, used with the XPER x-ray systems. The modification on the table is the cables used for connecting to the XPER systems.

FDA Recall Z-0208-06 · 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 Quantitysee total above

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.

K041949ALLURA XPER FD10Philips Medical Systems North America Co. · 2004-07-30K033737ALLURA 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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