—#42985

Product

AD6 table, modified, used with the XPER systems. The modification on the table is the cables used for connecting to the XPER systems.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033737, K041949
Affected lot / code info: see site numbers listed above

Why it was recalled

Potential for high voltage exposure involving the injector interface connector of patient support tables.

Root cause (FDA determination)

Other

Action the firm took

On 10/10/05 the firm issued a letter to customers alerting customers to the problem and advising that the firm will perform an upgrade to the devices at customer sites. In March 2006 the firm issued a second notification letter involving more units.

Recalling firm

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

Distribution

Distribution pattern: Devices were distributed nationwide to hospitals/medical centers.

Timeline

Recall initiated: 2005-10-12
Posted by FDA: 2005-11-29
Terminated: 2011-03-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42985. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.