Z-1311-2010
Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positioning patients...
KaVo Dental Technologies, LLC / initiated 2010-02-09 / Terminated
Pelton & Crane Company began a recall of Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positioning patients to perform dental procedures on . The reason FDA records is "The Dental Chair lacks a valid Device History Record". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1311-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- KaVo Dental Technologies, LLC
- Product
- Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positioning patients to perform dental procedures.
- Product code
- KLC Chair, Dental, With Operative Unit
- Reason for recall
- The Dental Chair lacks a valid Device History Record.
- FDA root cause
- Other
- Action
- An "URGENT MEDICAL DEVICE RECALL" letter dated February 9, 2010, was delivered in person to the customer. The letter describe the product, problem and action to be taken by the customer. The customer was requested to provide the name and location of the consignee who received the chair so that Pelton & Crane can contact the end user to arrange to replace the affected chair with a new dental chair, and to complete the enclosed Recall Acknowledgement/Return Form and fax to (704) 587-7204. A monthly status report will be submitted to FDA. Please contact Pelton & Crane Customer Care at 1-800-659-6560 or call Mr. Frank Ray directly at 704-587-7227 to let us know where the device is currently stored.
- Quantity in commerce
- 1 unit
- Distribution
- Nationwide distribution: NC
- Product codes and lots
- Catalog number: 3003, Model number: SP30, Chair Serial #14736
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