Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0208-06

AD5 table, modified, used with the XPER x-ray 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 AD5 table, modified, used with the XPER x-ray 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-0208-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
AD5 table, modified, used with the XPER x-ray 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