Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1851-2011

Pelton & Crane Spirit 1800 dental chair (Model #SP18)

KaVo Dental Technologies, LLC / initiated 2011-03-04 / Terminated / root cause: manufacturing process

Pelton & Crane Company began a recall of Pelton & Crane Spirit 1800 dental chair (Model #SP18) on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1851-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
KaVo Dental Technologies, LLC
Product
Pelton & Crane Spirit 1800 dental chair (Model #SP18)
Product code
NRU Chair, Dental, Without Operative Unit
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.
Root cause tag
manufacturing process
FDA 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 in commerce
6 units
Distribution
Distribution to USA, Canada, and the Netherlands.
Product codes and lots
Agency model #SP18, Catalog model #1802 and 1803, all units.