Z-0617-2011

The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal) PercuNav Image...

Name: Z-0617-2011 The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal) PercuNav Image...
Creator: Philips Healthcare Inc.
Published: 2010-11-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-11-10 / Terminated / root cause: packaging

FDA source

Philips Healthcare Inc. began a recall of The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal) PercuNav Image Guided Intervention System. Some of the clinical... on 2010-11-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0617-2011
Status: Terminated
Initiated: 2010-11-10
Posted: 2010-12-14
Terminated: 2011-08-15
Recalling firm: Philips North America LLC
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".
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: packaging
FDA 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, 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.
Product codes and lots: Lot codes and Expiry Date: I280903 (09-2012); C151005 (03-2013); E111003 (05-2013); and E251002 (05-2013).

Product code JAK

K053610Class IIAbarisTraxtal Technologies, Inc. / cleared 2006-04-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)