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FDA Medical Device Recalls (openFDA)

Allen Medical Systems: Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No: MDTNA2

Recall number
Z-1327-04
Recalling firm
Allen Medical Systems
Product
Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No: MDTNA2
Status
Terminated
Initiated
2004-07-12
Posted
2004-08-07
Terminated
2005-05-05
Reason
Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement
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
29 units
Distribution
SC
Lot, serial or model codes
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
510(k) numbers
not on file
PMA numbers
not on file
Product code
FQO
Firm FEI
not on file
Firm city
Acton
Firm state
MA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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