Siemens Medical Solutions USA, Inc: AXIOM Artis. Angiographic X-ray System.

Recall number

Z-0193-2009

Recalling firm

Siemens Medical Solutions USA, Inc

Product

AXIOM Artis. Angiographic X-ray System.

Status

Terminated

Initiated

2008-08-22

Posted

2008-11-04

Terminated

2009-09-23

Reason

Patients could possibly fall off the table if not properly secured when: 1) moving them onto the patient table, 2) moving them on the patient table or 3) removing them from the patient table.

Root cause

Labeling design

Action

The recalling firm issued a Customer Safety Advisory Notice dated 7/04/08 (including an Addendum to the Operators Manual) which alerts the operator of possible injury to patients if they are not properly secured to the table during examinations and describes the recommended fastening procedures required to properly secure the patient to the table. For questions or additional information, contact Siemens Medical Solutions, Inc. at 610-448-4634.

Quantity

1,530 units

Distribution

Nationwide Distribution.

Lot, serial or model codes

Serial numbers: 10012, 10013, 10014, 10017, 10020, 10026, 10028, 10029, 10031, 10036, 10041, 10042, 10046, 10047, 10051, 10052, 10053, 10060, 10063, 10064, 10067, 10070, 10072, 10073, 10075, 10078, 10081, 10082, 10083, 10084, 10089, 10092, 10093, 10094, 10096, 10099, 10101, 10116, 10121, 10122, 10123, 10124, 10129, 10131, 10134, 10135, 10136, 10138, 10141, 10142, 10143, 10149, 10150, 10156, 10157, 10158, 10159, 10161, 10167, 10171, 10173, 10175, 10176, 10179, 10180, 10182, 10188, 10192, 10195, 10196, 10197, 10198, 10210, 10217, 10218, 10223, 10226, 10229, 10231, 10232, 10233, 10234, 10235, 10238, 10240, 10241, 10242, 10245, 10246, 10248, 10251, 10252, 10254, 10255, 10257, 10258, 10259, 10261, 10263, 10265, 10266, 10275, 10280, 10284, 10292, 10293, 10295, 10296, 10298, 10299, 10300, 10302, 10303, 10304, 10305, 10307, 10308, 10309, 10310, 10314, 10321, 10326, 10327, 10328, 10329, 10331, 10332, 10333, 10336, 10337, 10338, 10340, 10343, 10345, 10346, 10350, 10355, 10356, 10357, 10364, 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510(k) numbers

["K010721"]

PMA numbers

not on file

Product code

IZI

Firm FEI

2240869

Firm city

Malvern

Firm state

PA

Firm country

not on file

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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