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Terminated

Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000

FDA Recall Z-0810-06 · Posted 2006-04-27

Recalling FirmMacan Engineering and Manufacturing Co., Inc.
Recall StatusTerminated
Product CodeEKZ
Date Initiated2006-04-05
Date Terminated2008-03-24
Product Quantity455 units

Reason for Recall

The product label fails to warn users to use the device on patients with shielded pacemakers only.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052622MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNITMacan Engineering Co. · 2005-12-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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