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Terminated

FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector

FDA Recall Z-0370-2007 · Posted 2007-01-25

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeIZI
Date Initiated2006-12-14
Date Terminated2011-10-14
Product Quantity140 devices total

Reason for Recall

Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.

Firm Action

On 12/14/05 and 12/20/06 the firm issued a letter dated 12/12/06 to their customers. The letter explains the problem and states that the firm will be performing mandatory upgrades to correct the situation. Consignees will be contacted to arrange for service.

Root Cause

Other

Distribution Pattern

Units were distributed to hospitals and medical centers nationwide.

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. · 2003-05-13

Official Source

View FDA Recall →

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

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