Recall Z-1030-2013— Integra Burlington MA, Inc.

Name: FDA recall Z-1030-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-18

Class II · Terminated

Class II FDA medical device recall by Integra Burlington MA, Inc., initiated 2013-03-18, terminated 2014-02-25. It names one FDA 510(k) clearance: K924226. Product: Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.. Reason: If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury..

Recalling firm: Integra Burlington MA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-18
Terminated: 2014-02-25
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K924226 — OJEMANN CORTICAL STIMULATORRadionics, Inc.·cleared 1993-04-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

Reason for recall

If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury.

Data sourced from openFDA. This site is unofficial and independent of the FDA.