Recall Z-0209-06 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
AD6 table, modified, used with the XPER 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 |