FDA Device recall Z-1030-2013
Integra Ojemann Cortical Stimulator
- FDA Device
- Class II
- terminated
- Published 2013-04-10
On 2013-04-10 the FDA classified a Class II recall of Integra Ojemann Cortical Stimulator by Integra Burlington Ma, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1030-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-18 |
| Published | 2013-04-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Burlington Ma |
| Distribution | US |
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.
Identifiers
| code_info | Serial Number Range: 1010 through 1380 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1030-2013%22
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