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Terminated

Mobilett XP Hybrid/Digital/CR Intended use: mobile x-ray system

FDA Recall Z-0718-2011 · Posted 2010-12-17

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZL
Date Initiated2010-10-04
Date Terminated2012-09-29
Product Quantity170 units

Reason for Recall

battery fuse

Firm Action

SIEMENS released a field update dated October 25, 2010, via SP011/10/S to the representatives. The update described issue and corrective action plan. The representatives are to visit each account to upgrade the systems with a new battery fuse and a new holder. If you have any questions regarding this report, please contact Quality Engineer by phone 610-448-3237 or email: [email protected] and Director, Product complaints & Field Support by phone 610-448-4634 or email: [email protected].

Root Cause

Other

Distribution Pattern

Nationwide distribution: AZ, CA, DC, MD, PA, SC and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033238MOBILETTE XP AND MOBILETT XPHYBRIDSiemens Medical Systems, Inc. · 2003-11-14

Official Source

View FDA Recall →

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

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