—#49760

Product

Allura Mono X-Ray System, angiographic - monoplane, analog Allura with a 12' and 15' Image Intensifier

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K984545
Affected lot / code info: site numbers provided in the product listing for Z-0366-2007

Why it was recalled

Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.

Root cause (FDA determination)

Other

Action the firm took

On 12/14/05 and 12/20/06 the firm issued a letter dated 12/12/06 to their customers. The letter explains the problem and states that the firm will be performing mandatory upgrades to correct the situation. Consignees will be contacted to arrange for service.

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 hospitals and medical centers nationwide.

Timeline

Recall initiated: 2006-12-14
Posted by FDA: 2007-01-25
Terminated: 2011-10-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49760. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.