Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the
FDA device recall Z-1325-2010 · posted 2010-04-01 · Terminated
Recall details
- Recalling firm
- Pelton & Crane Company
- Reason for recall
- Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KLC
- Quantity affected
- Total: 498 chairs and 619 replacement upholstery spare parts
- Distribution
- Worldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany.
- Date initiated
- 2010-02-24
- Date posted
- 2010-04-01
- Date terminated
- 2010-10-28
- Location
- Charlotte, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BI-CENTRIC SYSTEM (K760404) | Pelton & Crane Co. | 1976-08-23 |