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
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