The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED ITEM, NOT THE CHAIRS)

FDA device recall Z-2241-2010 · posted 2010-08-20 · Terminated

Recall details

Recalling firm

Dental Equipment LLC

Reason for recall

The magnetic headrest on certain dental chairs may affect the function/programming of some implantable pacemakers or defibrillators if the implanted device is programmed to respond to a magnet.

Action taken

DCI Equipment sent an "Urgent Field Safety Alert" letter dated March 15, 2010 to consignees advising them of the potential problem. The letter instructed that patients with implantable pacemakers or defibrillators should avoid dental chairs with the magnetic headrest. A warning label was sent with the letter for insertion into the product Use and Care manual for operator warning. Consignees were asked to complete a Field Safety Alert Acknowledgement/Return Form and fax to the firm. Consignees were requested to notify customers.Consignees may contact the firm at 503 537-3602.

Root cause

Other

Status

Terminated

Product code

NRU

Quantity affected

108

Distribution

Worldwide distribution in the USA and Canada.

Date initiated

2010-03-23

Date posted

2010-08-20

Date terminated

2012-01-04

Location

Newberg, OR