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U.S. Department of Health and Human Services

Class 2 Device Recall Pelton & Crane

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  Class 2 Device Recall Pelton & Crane see related information
Date Initiated by Firm February 20, 2012
Date Posted March 06, 2012
Recall Status1 Terminated 3 on March 28, 2012
Recall Number Z-1177-2012
Recall Event ID 61262
510(K)Number K946187  
Product Classification Unit, operative dental - Product Code EIA
Product Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273


Product Usage:
The intended use of the dental operative unit is for supplying power and to serve as a base for other dental devices, such as a dental hand piece, air/water syringe, oral cavity evacuator, a suction operative unit, and other dental devices. The TLC SAFEdrive option is an optional feature that monitors the operation of the high speed hand piece and gives an audible and visual signal to let the user know if the hand piece is potentially damaged or heating up.
Code Information Model #SET30, Catalog #3120, Serial numbers 4096 and 4099.
Recalling Firm/
Manufacturer		 Pelton & Crane Company
11727 Fruehauf Dr
Charlotte NC 28273
For Additional Information Contact Frank Ray
704-587-7227
Manufacturer Reason
for Recall		 Modification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up.
FDA Determined
Cause 2		 Employee error
Action Pelton & Crane sent an Urgent Medical Device Recall letter dated February 20, 2012 to all affected customers. The letter identifies the affected product, problem and actions to be taken. The letter states that a Pelton & Crane representative will be contacting the customers to schedule a service appointment with the end user of the device so that the affected TLC SAFEdrive circuit board can be replaced and returned to Pelton & Crane. Customers were instructed to complete the attached Recall Acknowledgement/Return Form and fax it to Pelton & Crane, attention Frank Ray, at (704) 587-7250. The letter also requested customers to mail the original Recall Acknowledgement/Return Form in the enclosed self addressed stamped envelope.
Quantity in Commerce 2 units
Distribution (USA) Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EIA and Original Applicant = PELTON & CRANE CO.
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