Z-0810-06

Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen...

Name: Z-0810-06 Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen...
Creator: Macan Engineering and Manufacturing Co., Inc.
Published: 2006-04-05
License: https://open.fda.gov/license/

Macan Genesis Manufacturing LLC / initiated 2006-04-05 / Terminated / root cause: labeling and UDI

FDA source

Macan Engineering and Manufacturing Co., Inc. began a recall of Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000 on 2006-04-05. The reason FDA records is "The product label fails to warn users to use the device on patients with shielded pacemakers only". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0810-06
Status: Terminated
Initiated: 2006-04-05
Posted: 2006-04-27
Terminated: 2008-03-24
Recalling firm: Macan Genesis Manufacturing LLC
Product: Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000
Product code: EKZ Unit, Electrosurgical, And Accessories, Dental
Reason for recall: The product label fails to warn users to use the device on patients with shielded pacemakers only.
Root cause tag: labeling and UDI
FDA 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 requesting that they place the enclosed label with the required warnings on the device, and complete and return the response sheet.
Quantity in commerce: 455 units
Distribution: Nationwide and Canada
Product codes and lots: Model MC-4A, serial numbers 7001 to 7456

Product code EKZ

K052622Class IIMacan Model Mc-4A Dental Electrosurgical UnitMacan Engineering Co. / cleared 2005-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)