Pelton & Crane Spirit 3000 dental chair (Model #SP30)

FDA device recall Z-1850-2011 · posted 2011-03-30 · Terminated

Recall details

Recalling firm

Pelton & Crane Company

Reason for recall

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

NRU

Quantity affected

9 units

Distribution

Distribution to USA, Canada, and the Netherlands.

Date initiated

2011-03-04

Date posted

2011-03-30

Date terminated

2011-08-16

Location

Charlotte, NC