Recall Z-1177-2012 ยท EIA Unit, Operative Dental
Pelton & Crane Company
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
| Date | Mar 6, 2012 (initiated Feb 20, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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. Th |
| Quantity | 2 units |
| Distribution | (USA) Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946187 | SPIRIT II AND SPIRIT TREATMENT CENTER Pelton & Crane Co., Mar 1, 1995 |