The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal) PercuNav Image Guided Interven
FDA device recall Z-0617-2011 · posted 2010-12-14 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- 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.
- Action taken
- 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, broken or soiled. The firm's representative will contact the consignees to confirm quantities and Lot Codes of MP008R-B Button Probes that the firm may have examined or discarded. The firm estimates replacement probes will be available in the first quarter of 2011. Consignees can contact Philips Customer Service at 800 722-9377 and reference the FCO 79500189.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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.
- Date initiated
- 2010-11-10
- Date posted
- 2010-12-14
- Date terminated
- 2011-08-15
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABARIS (K053610) | Traxtal Technologies, Inc. | 2006-04-19 |