Instatrak System with Multiple Dataset Navigation, Model IT3500

510(k) K040050

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK040050	Date24 Mar 2004Cleared	StatusActive

6 recalls · FDA

2 recalls, same reason
- Terminated Z-1941-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
- Terminated Z-1942-2011 FDA Unclassified (pre-2012) initiated 24 Feb 2011
Sensor cables may suffer material degradation when exposed to certain sterilization procedures.
- Terminated Z-1985-2012 FDA Class I initiated 15 Sep 2006
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System with Software version 5.2, the surgical Navigation and Visualization Application due to software related issues.
- Terminated Z-0691-05 FDA Unclassified (pre-2012) initiated 13 Dec 2004
Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
- Terminated Z-0155-05 FDA Unclassified (pre-2012) initiated 15 Sep 2004
Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove.
- Terminated Z-0815-05 FDA Unclassified (pre-2012) initiated 12 Jul 2004
Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

1 jurisdiction

United States — FDA 510(k) Active

510(k)