Recall Z-1179-2010 ยท KLC Chair, Dental, With Operative Unit
Pelton & Crane Company
Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to perform dental procedures.
| Date | Apr 1, 2010 (initiated Feb 24, 2010) |
| Status | Terminated |
| Reason | Magnetic headrests may affect patients with implantable pacemakers and defibrillators. |
| Root cause | Device Design |
| Action | Pelton & Crane Issued an "Urgent Field Safety Alert" notification dated February 24, 2010. Consignees were instructed of the affected product and informed of proper actions to take. For further information, contact Pelton & Crane at 1-704-588-2126. |
| Quantity | Total: 498 chairs and 619 replacement upholstery spare parts |
| Distribution | Worldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K760404 | BI-CENTRIC SYSTEM Pelton & Crane Co., Aug 23, 1976 |