Z-0896-05

View Forum 2003 software, SW 3.4L1

Name: Z-0896-05 View Forum 2003 software, SW 3.4L1
Creator: Philips Medical Systems North America Co. Phillips
Published: 2005-04-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2005-04-29 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of View Forum 2003 software, SW 3.4L1 on 2005-04-29. The reason FDA records is "Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0896-05
Status: Terminated
Initiated: 2005-04-29
Posted: 2005-06-16
Terminated: 2008-05-09
Recalling firm: Philips North America LLC
Product: View Forum 2003 software, SW 3.4L1
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.
Root cause tag: software
FDA root cause: Other
Action: On 4/29/05 the firm mailed a letter, via certified return receipt. to their customers. The letter notified users of the problem and offered a work around. Consignees were advised they would be contacted by a representative to upgrade the unit with new software.
Quantity in commerce: 18 units
Distribution: The units were distributed to 18 medical centers thorughout the US.
Product codes and lots: The firm utilizes site numbers: 534544, 520177, 520633, 532261, 504927, 532134, 534573, 531862, 521928, 522027, 521424, 533804, 532053

Product code LLZ

K032096Class IIPhilips Viewforum 2003Philips Medical Systems / cleared 2003-07-18

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)