Z-0640-05

Xcelera R1.2 Cardiology image and information management solution software

Name: Z-0640-05 Xcelera R1.2 Cardiology image and information management solution software
Creator: Philips Medical Systems Sales & Service Region No. America
Published: 2004-12-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-12-21 / Terminated

FDA source

Philips Medical Systems Sales & Service Region No. America began a recall of Xcelera R1.2 Cardiology image and information management solution software on 2004-12-21. The reason FDA records is "Loss of image data from image repository and archive requiring patients to undergo repeat imaging". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0640-05
Status: Terminated
Initiated: 2004-12-21
Posted: 2005-03-18
Terminated: 2006-02-10
Recalling firm: Philips North America LLC
Product: Xcelera R1.2 Cardiology image and information management solution software.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Loss of image data from image repository and archive requiring patients to undergo repeat imaging.
FDA root cause: Other
Action: The firm notified hospitals via letter sent 12/21/2004 stating the service organization will perform onsite upgrades.
Quantity in commerce: 33
Distribution: Hospitals and medical centers throughout the US.
Product codes and lots: Xcelera Software version R1.2

Product code LLZ

K022788Class IIPhilips Harmony Release 1Philips Medical Systems North America Co. / cleared 2002-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)