Recall Z-0617-2011 ยท JAK System, X-Ray, Tomography, Computed
Philips Healthcare Inc.
The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal) PercuNav Image Guided Intervention System. Some of the clinical applications of the Button Probe require sterility and others may not. However, it is possible that patient contamination could occur if a non-sterile Button Probe is used in clinical applications where aseptic technique is required. The devi
| Date | Dec 14, 2010 (initiated Nov 10, 2010) |
| Status | Terminated |
| Reason | The protective cover over the tip of the MP008R-B Button Probe may fall off, causing the probe tip to damage the packaging and compromise the sterility of the probe. |
| Root cause | Other |
| Action | On 11/10/10, Philips issued URGENT - Medical Device Recall notification letters dated November 10, 2010 to their consignees. Consignees are advised to examine their inventory of MP008R-B Button Probes to confirm the probe tip cover is properly placed over the tip of the probe. They should discard any Button Probes that have been confirmed to have the protective probe tip cover removed from the Button Probe tip. Consignees are also reminded to follow the MP008R-B Button Probe and PercuNav Instructions for Use prior to using the device. Do not use the probe if the unit package is damaged, bro |
| Quantity | 25 units |
| Distribution | Nationwide Distribution: in the states of FL, IL, MA, NE, NY, SC, and VA. There are no foreign consignees and US government consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053610 | ABARIS Traxtal Technologies, Inc., Apr 19, 2006 |