FDA Medical Device Recalls (openFDA)
Dental Equipment LLC: 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.
- Recall number
- Z-2241-2010
- Recalling firm
- Dental Equipment LLC
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-03-23
- Posted
- 2010-08-20
- Terminated
- 2012-01-04
- Reason
- 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.
- Root cause
- Other
- 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.
- Quantity
- 108
- Distribution
- Worldwide distribution in the USA and Canada.
- Lot, serial or model codes
- The individual headrests do not have serial numbers. The headrest has a part number of "40R501". The part number is followed by a dash and a 2 or 3 digit number that indicates the color of the vinyl covering.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NRU
- Firm FEI
- 1000523896
- Firm city
- Newberg
- Firm state
- OR
- 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