—#38888

Product

View Forum 2003 software, SW 3.4L1

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K032096
Affected lot / code info: The firm utilizes site numbers: 534544, 520177, 520633, 532261, 504927, 532134, 534573, 531862, 521928, 522027, 521424, 533804, 532053

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: The units were distributed to 18 medical centers thorughout the US.

Timeline

Recall initiated: 2005-04-29
Posted by FDA: 2005-06-16
Terminated: 2008-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38888. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.