—#27485

Product

Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs)

FDA product code: HBC — Motor, Drill, Electric
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K011444
Affected lot / code info: Serial Numbers: 50139962-2, 50128299-4, 50139968-5, 50139963-5, 50116580-5, 50128299-5, 50139964-2, 50139962-1, 50139971-2, 50139968-1, 50139964-3, 50128295-2, 50139964-1, 50139968-2, 50139964-4, 50128299-3, 50116576-2, 50128299-2, 50139968-3, 50139963-2, , 50139968-4, 50139963-4, 114766-1,114766-2

Why it was recalled

Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Dr., Palm Beach Gardens, Florida 33410

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2003-04-23
Posted by FDA: 2003-10-15
Terminated: 2003-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #27485. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.