—#64517

Product

Philips Omni Diagnost Eleva

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K032046
Affected lot / code info: Site numbers 500046, 520020, 521648, 522220, 533112, 533314, 533471, 533530, 535118, 535257, 535924, 539106, 540860, 541490

Why it was recalled

Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.

Root cause (FDA determination)

Other

Action the firm took

On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.

Recalling firm

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

Distribution

Distribution pattern: Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.

Timeline

Recall initiated: 2007-07-23
Posted by FDA: 2007-09-25
Terminated: 2012-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64517. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.