510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-0193-2009

AXIOM Artis. Angiographic X-ray System

Siemens Medical Solutions USA, Inc. / initiated 2008-08-22 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis. Angiographic X-ray System on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0193-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
AXIOM Artis. Angiographic X-ray System.
Product code
IZI System, X-Ray, Angiographic
Reason for recall
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 tag
labeling and UDI
FDA 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 in commerce
1,530 units
Distribution
Nationwide Distribution.
Product codes and lots
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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