Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill
FDA device recall Z-1243-03 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
- Action taken
- A recall notification letter was mailed to domestic consignees and faxed to international consignees on April 23, 2003. The letter requests return of the devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- HBC
- Quantity affected
- 24
- Distribution
- The devices were distributed to 12 domestic hosptials in FL, GA, NC, TX, CA, MA, MS as well as three international accounts in Taiwan, South Africa and Italy.
- Date initiated
- 2003-04-23
- Date posted
- 2003-10-15
- Date terminated
- 2003-09-22
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANSPACH EMAX DRILL SYSTEM (K011444) | The Anspach Effort, Inc. | 2001-08-08 |