Device Recall Pelton & Crane Spirit 1800 의 리콜

Recall

58105

Class 2

Z-1851-2011

2011-03-04

2011-03-30

Terminated

United States

2011-08-16

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98356

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.

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.