FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer
- Recall number
- Z-1506-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer
- Status
- Terminated
- Initiated
- 2012-02-22
- Posted
- 2012-05-10
- Terminated
- 2014-01-24
- Reason
- There is a potential malfunction in the connection of a Sensis EP system with Carto(R) 3 dedicated cable set (part number 14411343) with the Carto 3 system from Bionsense Webster.
- Root cause
- Nonconforming Material/Component
- Action
- Siemens sent a recall/correction letter dated February 22, 2012, via Update Instruction AX049/11/S of this product to all affected customers. The letter informed customers of the potential issues and provides additional information on the implemented resolution. An Update Instuction AX048/11/S will be available immediately. The update instruction provides a new version of the Carto 3 addendum to the Operator Manual and the exchange of the previous stim cables with the latest cable. For questions call 610-219-4834.
- Quantity
- 3
- Distribution
- Nationwide Distribution including FL, NC, and SC.
- Lot, serial or model codes
- Model number 10608285 - serial numbers 41021, 10006, and 6045.
- 510(k) numbers
- ["K020440"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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