FDA Medical Device Recalls (openFDA)
Pelton & Crane Company: Pelton & Crane Spirit 3000 dental chair (Model #SP30)
- Recall number
- Z-1850-2011
- Recalling firm
- Pelton & Crane Company
- Product
- Pelton & Crane Spirit 3000 dental chair (Model #SP30)
- Status
- Terminated
- Initiated
- 2011-03-04
- Posted
- 2011-03-30
- Terminated
- 2011-08-16
- Reason
- The Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair.
- Root cause
- Process control
- Action
- Pelton & Crane sent an "Urgent Medical Device Recall" letter dated 3/04/2011. They were instructed to: Locate the affected devices this recall is in regards to. Schedule service with the end user for Pelton & Crane representative to replace the affected components this recall is in regards to. International accounts were instructed to order link arm assemblies from Pelton & Crane and replace the affected components. All consignees were to complete the Recall Acknowledgement/Return Form and return the form to Pelton & Crane.
- Quantity
- 9 units
- Distribution
- Distribution to USA, Canada, and the Netherlands.
- Lot, serial or model codes
- Agency model #SP30, Catalog model #3003 and 3004, all units
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NRU
- Firm FEI
- 1017522
- Firm city
- Charlotte
- Firm state
- NC
- 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