The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED ITEM, NOT THE CHAIRS): The dental chairs are sold under the brand names Marus and DCI Equipment. The affected models are: Marus MaxStar-Agency Model # DC1490; Marus MaxStar-Agency Model # DC1690; Marus NuStar-Agency Model # DC1700; Marus NuStar-Agency Model # DC1702; Marus ProStar-Agency Model # DC1540; Marus ProStar-Agency Model # DC1535; DCI Equipment DC1235 Hydraulic-Agency Model # DC1235; and DCI Equipment DC1335 Electromechanical-Agency Model # DC1335.
FDA Recall Z-2241-2010 · Posted 2010-08-20
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Recalling FirmDental Equipment LLC
Recall StatusTerminated
Product CodeNRU
Date Initiated2010-03-23
Date Terminated2012-01-04
Product Quantity108
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.
Firm Action
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
Distribution Pattern
Worldwide distribution in the USA and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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