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 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".

Recall number

Z-0617-2011

Recalling firm

Philips Healthcare Inc.

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".

Status

Terminated

Initiated

2010-11-10

Posted

2010-12-14

Terminated

2011-08-15

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, 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

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.

Lot, serial or model codes

Lot codes and Expiry Date: I280903 (09-2012); C151005 (03-2013); E111003 (05-2013); and E251002 (05-2013).

510(k) numbers

["K053610"]

PMA numbers

not on file

Product code

JAK

Firm FEI

1218950

Firm city

Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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