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Terminated

Axiom Artis Zee. Angiographic X-ray System.

FDA Recall Z-0194-2009 · Posted 2008-11-04

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2008-08-22
Date Terminated2009-09-23
Product Quantity108 units

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.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K073290ARTIS ZEE AND ZEEGOSiemens Medical Solutions USA, Inc. · 2008-02-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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