Recalls / —
—#108334
Product
Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer
- FDA product code
- DQK — Computer, Diagnostic, Programmable
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K020440
- Affected lot / code info
- Model number 10608285 - serial numbers 41021, 10006, and 6045.
Why it was recalled
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 (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355
Distribution
- Distribution pattern
- Nationwide Distribution including FL, NC, and SC.
Timeline
- Recall initiated
- 2012-02-22
- Posted by FDA
- 2012-05-10
- Terminated
- 2014-01-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #108334. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.