FDA Medical Device Recalls (openFDA)
Cardinal Health NeuroCare Division: NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central control room.
- Recall number
- Z-2459-2008
- Recalling firm
- Cardinal Health NeuroCare Division
- Product
- NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central control room.
- Status
- Terminated
- Initiated
- 2008-06-13
- Posted
- 2008-09-23
- Terminated
- 2011-12-11
- Reason
- NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. Cardinal Health NeuroCare has confirmed that the 3rd party room relay connected to the A2 wall plate does not always activate if the patient event button connected to the CSeries Amplifier is pressed twice within one second.
- Root cause
- Software design
- Action
- Consignees were sent a "Cardinal Health Urgent: Medical Device Correction" letter dated June 23, 2008. The letter identified the product and problem. It also provided instructions (Field Correction) to install the software patch and requested return of the verification form. Contact Cardinal Health NeuroCare Division at 1-608-271-3333 for assistance.
- Quantity
- 274
- Distribution
- US: AL, AR, CA, CO, FL, GA, IL IN, KY, LA, MO MS, NC, NJ, NY, OH, PA, TN, TX, WA, and WI. OUS: CH, CN, DK, GB, HK, IN, NO, RU, and UK.
- Lot, serial or model codes
- PB070799 PB060399 PB060413 PB080901 PB070523 PBO80944 PB060414 PB060333 PB070817 PB070677 PB070669 PB PB060478 PB060207 PB080873 PB060234 PB060346 PB070605 PB060370 PB060461 OA040136R PB070844 PB070684 PB060421 PB060384 PB080890 PB060306 PB070837 PB070649 PB070638 OA050455 PB060192 PB070788 PB070746 PB060500 PB060227 PB070533 PB080999 PB060291 PB050140 PB070853 PB070673 PB070733 PB080980 PB070852 PB060511 PB060510 PB060383 PB060342 PB060502 PB080948 PB060465 PB060362 PB080995 OA050421 PB070749 PB070571 PB070718 PB080878 PB070861 PB060338 PB060353 PB070606 PB060386 PB050153 PB080953 OJ060318 OA040179R OJ060389 OJ060393 OJ060388 OJ060378 OJ060437 OJ060434 OJ060435 OJ060432 OJ060433 OJ070476 OJ070477 OJ070464 OJ070462 OJ070465 OJ070466 OJ070463 OJ070461 OJ070455 OJ070460 OJ070459 OJ070458 OJ070457 OJ070456 OJ070478 OJ070505 OJ070510 OJ070535 OJ070534 OJ070532 OJ070533 OJ070531 OJ070530 OJ070446 PB070591 PB070590 PB070754 PB070753 PB070765 PB070767 PB070766 PB070770 PB070771 PB070772 PB060191 PB070769 PB080924 OJ070498 OJ070489 OJ070527 OJ080542 OJ080555 OJ060314 OJ060341 OJ070479 OJ080548 OJ080554 OJ080553 OJ080560 OJ080581 OJ080559 OJ060321 OJ060320 OJ060323 OJ060322 OJ060324 OJ060325 OJ060327 OJ060328 OJ060326 PB060393 PB060469 PB070579 PB070582 PB070583 PB070580 PB070581 PB070578 PB070593 PB070665 and PB070820
- 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