SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
FDA device recall Z-2635-2014 · posted 2014-09-12 · Terminated
Recall details
- Recalling firm
- JK Products & Services, Inc
- Reason for recall
- The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process).
- Action taken
- The owners of the affected device will be notified via certified letter. After the recalling firm confirms ownership, a technician will be dispatched to install a door clamp and door stop, and inspect the condition of the main electrical chord.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LEJ
- Quantity affected
- 1948 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-07-25
- Date posted
- 2014-09-12
- Date terminated
- 2017-01-13
- Location
- Jonesboro, AR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUNDASH (K932483) | Sun Ind., Inc. | 1994-02-22 |