FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0810-06
- Recalling firm
- Macan Engineering and Manufacturing Co., Inc.
- Product
- Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000
- Status
- Terminated
- Initiated
- 2006-04-05
- Posted
- 2006-04-27
- Terminated
- 2008-03-24
- 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 requesting that they place the enclosed label with the required warnings on the device, and complete and return the response sheet.
- Quantity
- 455 units
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Model MC-4A, serial numbers 7001 to 7456
- 510(k) numbers
- ["K052622"]
- PMA numbers
- not on file
- Product code
- EKZ
- Firm FEI
- 1418975
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28