Z-2389-2008

NicoletOne photic adapter cable 085-463700

Name: Z-2389-2008 NicoletOne photic adapter cable 085-463700
Creator: Cardinal Health NeuroCare Division
Published: 2008-06-05
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-06-05 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health NeuroCare Division began a recall of NicoletOne photic adapter cable 085-463700 on 2008-06-05. The reason FDA records is "Cardinal Health NeuroCare is implementing a voluntary field correction to replace a quantity of photic adapter cables, part number 085-463700, used to connect the NicLED Photic Strobe option, part number 698-625500...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2389-2008
Status: Terminated
Initiated: 2008-06-05
Posted: 2008-09-21
Terminated: 2010-10-13
Recalling firm: Medtronic, Inc.
Product: NicoletOne photic adapter cable 085-463700
Product code: GWQ Full-Montage Standard Electroencephalograph
Reason for recall: Cardinal Health NeuroCare is implementing a voluntary field correction to replace a quantity of photic adapter cables, part number 085-463700, used to connect the NicLED Photic Strobe option, part number 698-625500, with NicoletOne EEG system. The photic adapter cable has a wiring error which delivers a reduced voltage and results in a decreased intensity of the NicLED photic. This reduced intensi
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A "Cardinal Health Urgent: Medical Device Correction" letter was sent to consignees. The letter described the product and the problem. The consignees were asked to confirm completion of the cable exchange by returning an information card. If you have questions, contact Cardinal Health (formerly VIASYS) NeuroCare Technical Support Group at 1-800-356-0007 (US), 608-273-5000 (OUS) or email [email protected].
Quantity in commerce: 92
Distribution: CA FL GA ID IN LA MD ME MI MO NC NY PA TN TX WA WI China Denmark Indonesia Japan Korea Mexico Netherlands Russia Saudi Arabia Slovenia
Product codes and lots: 085-463700

Product code GWQ

K991054Class IIBravo Multi-Modality SystemNicolet Biomedical, Inc. / cleared 1999-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)