Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Tech
FDA device recall Z-0933-2008 · posted 2008-03-13 · Terminated
Recall details
- Recalling firm
- Sound Surgical Technologies, LLC
- Reason for recall
- Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed.
- Action taken
- Consignees were sent an Advisory Notice on 12/28/2007. The notification describes the defect. Sound Surgical will be contacting facilities to arrange a service call to install new cables between the footswitch receiver and the VASER system. Facilities may contact the Technical Service Center at 1-888-677-8765.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 127 switches
- Distribution
- Worldwide Distribution including USA states of AL, CA, CT, FL, GA, IN, KY, LA, MI, NJ, NY, OH, OK, PA, TX, and VA. Foreign Distribution to Colombia, Costa Rica and Switzerland.
- Date initiated
- 2007-12-28
- Date posted
- 2008-03-13
- Date terminated
- 2008-04-01
- 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 |