FDAOctober 11, 2019device
ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intended t...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrode for an EEG study.
What to do
FDA enforcement status: Terminated
Brands named
lifelines neurolifelines
UPCs
00856310006351
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intend...2019-10-11
- FDAHomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.2017-11-13
- FDAItem # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red color kit: 845174005464; U...2016-05-16
- FDA5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.2016-05-16
- FDAPhilips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.2015-07-23
- FDANeuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and unt...2015-07-21
- FDAI-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. periphera...2015-04-30
- FDAPhilips GoSafe Communicator 7000L Personal emergency response system.2015-04-22
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →