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Terminated

Xcelera System, image processing, radiological.

FDA Recall Z-0973-04 · Posted 2004-07-20

Recalling FirmPhilips Medical Systems Sales & Service Region No. America
Recall StatusTerminated
Product CodeLLZ
Date Initiated2004-04-15
Date Terminated2005-04-11
Product Quantity56 units

Reason for Recall

Potential for the image data to be erased from the long term archive.

Firm Action

On 4/15/04 the firm sent letters to customers advising of the problem and that a service representative will visit and conduct a software upgrade.

Root Cause

Other

Distribution Pattern

Devices were distributed to hospitals and medical centers throughout the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022788PHILIPS HARMONY RELEASE 1Philips Medical Systems North America Co. · 2002-10-25

Official Source

View FDA Recall →

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

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