Recall Z-0208-06 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
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.
| Date | Nov 29, 2005 (initiated Oct 12, 2005) |
| Status | Terminated |
| Reason | Potential for high voltage exposure involving the injector interface connector of patient support tables. |
| 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 | see total above |
| Distribution | Devices were distributed nationwide to hospitals/medical centers. |
| FDA record | Open on fda.gov |