Z-1474-2011

Aesculap MicroSpeed Uni Control Box, Part #GD670 Intended for high speed cutting, sawing, drilling and...

Name: Z-1474-2011 Aesculap MicroSpeed Uni Control Box, Part #GD670 Intended for high speed cutting, sawing, drilling and...
Creator: Aesculap Inc
Published: 2010-11-22
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2010-11-22 / Terminated / root cause: software

FDA source

Aesculap Inc began a recall of Aesculap MicroSpeed Uni Control Box, Part #GD670 Intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of... on 2010-11-22. The reason FDA records is "Potential safety issue in that the control box can misinterpret the information sent from the low speed motor if the control magnet inside the motor changes its posthion". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1474-2011
Status: Terminated
Initiated: 2010-11-22
Posted: 2011-03-02
Terminated: 2012-07-05
Recalling firm: Aesculap Inc
Product: Aesculap MicroSpeed Uni Control Box, Part #GD670 Intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro and Maxillo facial Surgery.
Product code: HBC Motor, Drill, Electric
Reason for recall: Potential safety issue in that the control box can misinterpret the information sent from the low speed motor if the control magnet inside the motor changes its posthion.
Root cause tag: software
FDA root cause: Software design
Action: AESCULAP sent an IMPORTANT CORRECTION NOTICE letter dated November 22, 2010, to all affected consignees. The letter identified the product, the problem, and the action the consignee should take. Consignees were instructed to not use the motors for thread cutting and removal of screws. If any unusual reactions of any cutting tools were observed consignees should check to ensure that the motor is not running in the opposite direction. If any error message is displayed, consigness were instructed to not use the motor. Consignees were also instructed to check both directions of running before use and do not use a motor which produces an error message in one direction. Aesculap would be providing all customers with a software update to the MicroSpeed Uni control box either by the unit being returned to Aesculap for update or by firm representative doing the upgrade on site at their facility. For questions regarding this recall call 800-258-1946 x5254 or 800-258-1946 x5267.
Quantity in commerce: 91 units
Distribution: Worldwide Distribution - USA including CA, CO, DE, FL, GA, IN, LA, MO, NC, NJ, OK, PA, TN, TX, and VA and the country of Canada.
Product codes and lots: Part #GD670 - all distributed lot numbers and serial numbers

Product code HBC

K053526Class IIMicrospeed Uni Motor SystemAesculap, Inc. / cleared 2006-01-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)