FDA Medical Device Recalls (openFDA)
Cardinal Health NeuroCare Division: NicoletOne photic adapter cable 085-463700
- Recall number
- Z-2389-2008
- Recalling firm
- Cardinal Health NeuroCare Division
- Product
- NicoletOne photic adapter cable 085-463700
- Status
- Terminated
- Initiated
- 2008-06-05
- Posted
- 2008-09-21
- Terminated
- 2010-10-13
- Reason
- 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
- 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 shane.sawall@cardinalhealth.com.
- Quantity
- 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
- Lot, serial or model codes
- 085-463700
- 510(k) numbers
- ["K991054"]
- PMA numbers
- not on file
- Product code
- GWQ
- Firm FEI
- 3010611950
- Firm city
- Madison
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28