Recall Z-1368-2011 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 and Allura CV20. Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
| Date | Mar 22, 2011 (initiated Nov 4, 2010) |
| Status | Terminated |
| Reason | Adjustment of the micro-switches in the footswitch used on the Philips cardiovascular X-ray systems was not implemented. If it is programmed for exposure, it is possible that after pressing the pedal on the footswitch it does not release itself. The patient may be exposed to X-ray longer than intended. |
| Root cause | Pending |
| Action | On 11/5/10, Philips began sending the Electronic Product Radiation Warning notification letter, dated November 4, 2010, to their consignees. The consignees were informed that the middle pedal of the foot switch of the Allura FD10, FD20, CV20 systems, and the Allura Field Extension series does not not always become inactive (sticks) when pedal is released. The function of the middle pedal on the foot switch is freely programmable by the customer. If it is programmed for exposure and if the pedal does not release by itself, the patient will be exposed to X-ray longer than intended. The co |
| Quantity | 4 units |
| Distribution | Worldwide Distribution -- US, including states of CA, IL, MA, NC, and OC. |
| FDA record | Open on fda.gov |