Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14663 |
| Brand Name: | Integra Ojemann Stimulator Unit |
| Model: | Catalogue: OCS2 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Integra Neurosciences Pty Ltd (NZ) 12 Florence Avenue Orewa Auckland 0931 |
| Contact Information: | 0800 400 660 |
| Manufacturer: | Integra Burlington MA Inc |
| Issue: | Areas of the current design of the Ojemann Cortical Stimulator (OCS2) were found not to be compliant to IEC 60601-1, contraindicating the claim in the IFU. Through internal evaluation, the manufacturer found that if the optional headphone jack is in use during a surgical procedure, 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 be a potential source of injury. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/5/2013 |
