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U.S. Department of Health and Human Services

Class 2 Device Recall Macan Model MC4A Dental Electrosurgical Unit

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 Class 2 Device Recall Macan Model MC4A Dental Electrosurgical Unitsee related information
Date Initiated by FirmApril 05, 2006
Date PostedApril 27, 2006
Recall Status1 Terminated 3 on March 24, 2008
Recall NumberZ-0810-06
Recall Event ID 34948
510(K)NumberK052622 
Product Classification Unit, Electrosurgical, And Accessories, Dental - Product Code EKZ
ProductMacan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000
Code Information Model MC-4A, serial numbers 7001 to 7456
FEI Number 1418975
Recalling Firm/
Manufacturer		 Macan Engineering and Manufacturing Co., Inc.
1564 N Damen Ave
Chicago IL 60622-1942
For Additional Information ContactMs. Mildred Albergo
866-622-2611
Manufacturer Reason
for Recall		The product label fails to warn users to use the device on patients with shielded pacemakers only.
FDA Determined
Cause 2		Other
ActionProduct 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 Commerce455 units
DistributionNationwide and Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = EKZ
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