Recall Z-1850-2011 ยท NRU Chair, Dental, Without Operative Unit
Pelton & Crane Company
Pelton & Crane Spirit 3000 dental chair (Model #SP30)
| Date | Mar 30, 2011 (initiated Mar 4, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 9 units |
| Distribution | Distribution to USA, Canada, and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.