LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURED BY: MISONIX, INC. EXCLUSIVEL
FDA device recall Z-0070-04 · posted 2003-10-30 · Terminated
Recall details
- Recalling firm
- Misonix, Inc
- Reason for recall
- Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. The misalignment causes additional voltage to appear on the patient probe.
- Action taken
- Misonix, Inc. notified the sole direct consignee, Byron Medical Inc., of the "Corrective Action" by letter on 8/13/03. On 9/17/03, Byron Medical Inc. notified the end users by letter, and provided instructions for proper assembly and warning labels to be affixed to the units.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFL
- Quantity affected
- 1119 units (potentially)
- Distribution
- 1 distributor in Tucson, AZ, for further distribution to end users (physicians and medical facilities) nationwide & Puerto Rico, and in the following countries: Canada, Mexico, Australia, Switzerland,
- Date initiated
- 2003-08-13
- Date posted
- 2003-10-30
- Date terminated
- 2005-02-07
- Location
- Farmingdale, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLIGER ULTRASONIC SURGICAL SYSTEM (K933559) | Medsonic, Inc. | 1993-10-15 |