Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindberg
FDA device recall Z-0556-06 · posted 2006-02-23 · Terminated
Recall details
- Recalling firm
- Lumenis Inc.
- Reason for recall
- During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.
- Action taken
- On 2/9/06, the firm initiated the recall and its notification was via letters informing its customers of the corrective action. In May 2005, Lumenis mailed a 'Dear Doctor' letter to LightSheer Diode Laser System customers describing more detailed cleaning procedures to be used on the sapphire tips due to skin burns patients' were experiencing from debris build-up on the tip.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 3,426 units
- Distribution
- The product was released for distribution to 3,426 consignees nationwide. There are 48 international consignees.
- Date initiated
- 2006-02-09
- Date posted
- 2006-02-23
- Date terminated
- 2006-08-28
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (K003614) | Coherent Star | 2001-03-13 |