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U.S. Department of Health and Human Services

Class 2 Device Recall PercuNav MP008RB Button Probe

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  Class 2 Device Recall PercuNav MP008RB Button Probe see related information
Date Initiated by Firm November 10, 2010
Date Posted December 14, 2010
Recall Status1 Terminated 3 on August 15, 2011
Recall Number Z-0617-2011
Recall Event ID 57223
510(K)Number K053610  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product 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 device's labeled in part: " TRAXTAL PERCUNAV...(1) Button Probe Right hand version, 25mm...Traxtal Inc...49 Spadina Avenue, Suite 310 Toronto, ON Canada M5V 2J1...Made In Canada...www.traxtal.com...STERILE...For use with Traxtal's PercuNav system only. Do not use if package is opened or damaged. Dispose of safely after single use to avoid risk of infection...Rx only...Use immediately after opening unit package. Store at room temperature".
Code Information Lot codes and Expiry Date: I280903 (09-2012); C151005 (03-2013); E111003 (05-2013); and E251002 (05-2013).
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Philips Customer Service
978-687-1501
Manufacturer 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.
FDA Determined
Cause 2		 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, 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = TRAXTAL TECHNOLOGIES INC.
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