Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago,
FDA device recall Z-0810-06 · posted 2006-04-27 · Terminated
Recall details
- Recalling firm
- Macan Engineering and Manufacturing Co., Inc.
- Reason for recall
- The product label fails to warn users to use the device on patients with shielded pacemakers only.
- Action taken
- 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 requesting that they place the enclosed label with the required warnings on the device, and complete and return the response sheet.
- Root cause
- Other
- Status
- Terminated
- Product code
- EKZ
- Quantity affected
- 455 units
- Distribution
- Nationwide and Canada
- Date initiated
- 2006-04-05
- Date posted
- 2006-04-27
- Date terminated
- 2008-03-24
- Location
- Chicago, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT (K052622) | Macan Engineering Co. | 2005-12-09 |