Recall Z-0810-06 ยท EKZ Unit, Electrosurgical, And Accessories, Dental
Macan Engineering and Manufacturing Co., Inc.
Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000
| Date | Apr 27, 2006 (initiated Apr 5, 2006) |
| Status | Terminated |
| Reason | The product label fails to warn users to use the device on patients with shielded pacemakers only. |
| Root cause | Other |
| Action | Product recall letters dated 4/5/06 were sent to the distributors, along with recall packages dated 3/23/06, to be sent out to their customers who purchased a MC-4A instrument. The recall packages consist of a customer letter dated 3/23/06, a new warning label - part number 4ALB-001, installation instructions for the label placement, a customer response sheet, and a self-addressed stamped return envelope for the response sheet. The customer letter informs the customers that the old device label lacked adequate information regarding the use of the instrument on patients with pacemakers, and re |
| Quantity | 455 units |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052622 | MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT Macan Engineering Co., Dec 9, 2005 |