Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0209-06

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

Philips North America LLC / initiated 2005-10-12 / Terminated

Philips Medical Systems North America Co. Phillips began a recall of AD6 table, modified, used with the XPER systems. The modification on the table is the cables used for connecting to the XPER systems on . The reason FDA records is "Potential for high voltage exposure involving the injector interface connector of patient support tables". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0209-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
AD6 table, modified, used with the XPER systems. The modification on the table is the cables used for connecting to the XPER systems.
Product code
IZI System, X-Ray, Angiographic
Reason for recall
Potential for high voltage exposure involving the injector interface connector of patient support tables.
FDA root cause
Other
Action
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.
Quantity in commerce
see total above
Distribution
Devices were distributed nationwide to hospitals/medical centers.
Product codes and lots
see site numbers listed above