FDA Medical Device Recalls (openFDA)
Sound Surgical Technologies, LLC: Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027
- Recall number
- Z-0939-2011
- Recalling firm
- Sound Surgical Technologies, LLC
- Product
- Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027
- Status
- Terminated
- Initiated
- 2010-12-21
- Posted
- 2011-01-25
- Terminated
- 2011-02-08
- Reason
- Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.
- Root cause
- Process control
- Action
- Customers were notified by e-mail with an Advisory Notice on 12/21/2010. The Notice identified the affected product and described the issue. The Notice also explained what the potential hazard involved along with a mechanism to eliminate the potential hazard. Sound Surgical would arrange a service call to implement the correction at the firm's expense. If customers experience this potential failure, they are to contact Sound Surgical Technologies at 1-888-677-8765 or 1-888-471-4777.
- Quantity
- 27 units
- Distribution
- Nationwide Distribution -- AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, MA, MI, MO, NJ, NY, PA, and TX .
- Lot, serial or model codes
- Serial numbers VNT10-0102 thru VNT10-0128.
- 510(k) numbers
- ["K022051","K053510","K991791","K993868"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3004106598
- Firm city
- Louisville
- Firm state
- CO
- 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