AD5 table, modified, used with the XPER x-ray systems. The modification on the table is the cables used for connecting t
FDA device recall Z-0208-06 · posted 2005-11-29 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Potential for high voltage exposure involving the injector interface connector of patient support tables.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- see total above
- Distribution
- Devices were distributed nationwide to hospitals/medical centers.
- Date initiated
- 2005-10-12
- Date posted
- 2005-11-29
- Date terminated
- 2011-03-09
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLURA XPER FD10 (K041949) | Philips Medical Systems North America Co. | 2004-07-30 |
| ALLURA XPER FD20 (K033737) | Philips Medical Systems North America, Inc. | 2003-12-09 |