Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd.,
FDA device recall Z-0939-2011 · posted 2011-01-25 · Terminated
Recall details
- Recalling firm
- Sound Surgical Technologies, LLC
- Reason for recall
- Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 27 units
- Distribution
- Nationwide Distribution -- AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, MA, MI, MO, NJ, NY, PA, and TX .
- Date initiated
- 2010-12-21
- Date posted
- 2011-01-25
- Date terminated
- 2011-02-08
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IR WIRELESS FOOT SWITCH (K053510) | Linemaster Switch Corp. | 2006-03-20 |
| SOUNDVASER SYSTEM (K022051) | Sound Surgical Technologies, LLC | 2002-09-11 |
| THE SOUNDVASER DISSECTION SYSTEM (K993868) | Sound Surgical Technologies, LLC | 1999-12-21 |
| SOUND VASER SYSTEM (K991791) | Sound Surgical Technologies, LLC | 1999-08-12 |