Recall Z-2219-2011 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems North America Co. Phillips
PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911. Designed to be used only with the PercuNav" image guided intervention system. The Field Generator Stand (with articulating Mounting Arm) is used to position the Field Generator near the area of interest.
| Date | May 19, 2011 (initiated Apr 1, 2011) |
| Status | Terminated |
| Reason | The PercuNav Field Generator Stand could tip over during set up, during use, or during transport. |
| Root cause | Device Design |
| Action | On 4/4/11, Philips Healthcare began sending out the URGENT-Medical Device Correction notification letter to their consignees. Philips informed their customers of a potential tipping hazard of the PercuNav Field Generator Stand. The notification letter also provides instructions to customers to ensure the articulating Mounting Arm is positioned so the Field Generator is not further than the specified distance from the back of the clamp on the stand's central pole during set up or during use. Customers are instructed to apply a provided label on stand to warn of a potential for tipping du |
| Quantity | 65 units total (33 units distributed to US and 32 units to foreign consignees) |
| Distribution | Worldwide Distribution -- USA, Australia, Austria, Belgium, China, France, Germany, Hong Kong, India, Korea, Netherlands, Singapore, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053610 | ABARIS Traxtal Technologies, Inc., Apr 19, 2006 |