Z-1327-04

Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No...

Name: Z-1327-04 Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No...
Creator: Allen Medical Systems
Published: 2004-07-12
License: https://open.fda.gov/license/

Allen Medical Systems, Inc. / initiated 2004-07-12 / Terminated

FDA source

Allen Medical Systems began a recall of Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No: MDTNA2 on 2004-07-12. The reason FDA records is "Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1327-04
Status: Terminated
Initiated: 2004-07-12
Posted: 2004-08-07
Terminated: 2005-05-05
Recalling firm: Allen Medical Systems, Inc.
Product: Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No: MDTNA2
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement
FDA root cause: Other
Action: Allen Medical notified the two distributors by telephone on 7/12/04 and 7/16/04. A customer notifcation letter issued requesting return of the device for correction.
Quantity in commerce: 29 units
Distribution: SC
Product codes and lots: 131613, 131614, 131615, 131616,152144, 152145, 152147, 152148 219039, 219040, 219042, 219043, 232800, 232801, 232802, 232803, 232804, 205395, 205396, 235327, 235329, 235330, 237473, 237465, 237467, 237468, 237469, 237470, 237471

Product code FQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)