The August 20 FDA Enforcement Report, published weekly by the FDA, Department of Health and Human Services, contains information on actions taken in connection with agency Regulatory activities.

The Recalls and Field Corrections: Devices—Class II section advises that Philips Healthcare Informatics Inc, Foster City, Calif, initiated a recall by letter on February 20, 2008 for two versions of the Philips Medical Systems iSite picture archiving and communications systems (PACS).

When using the freehand region of interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a discrepancy exists in the measurement provided by the tool. The Enforcement Report lists specific product information.

The report also lists the extensive serial and lot numbers related to the Viasys Healthcare, pulmonetic systems LTV 1000, LTV 950, LTV 900, and LTV 800 ventilators.

Initiated by Cardinal Health 203 Inc, Minneapolis, by letter, February 22, 2008 and again March 4, 2008, the firm has recalled the products because the failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.

The 14,034 ventilators and 6,549 circuit boards being recalled were distributed nationally and internationally.