Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273 Pro
FDA device recall Z-1177-2012 · posted 2012-03-06 · Terminated
Recall details
- Recalling firm
- Pelton & Crane Company
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- EIA
- Quantity affected
- 2 units
- Distribution
- (USA) Nationwide Distribution
- Date initiated
- 2012-02-20
- Date posted
- 2012-03-06
- Date terminated
- 2012-03-28
- Location
- Charlotte, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPIRIT II AND SPIRIT TREATMENT CENTER (K946187) | Pelton & Crane Co. | 1995-03-01 |