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Terminated

Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobile

FDA Recall Z-0171-2011 · Posted 2010-11-01

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZL
Date Initiated2010-10-04
Date Terminated2012-09-29
Product Quantity177 units

Reason for Recall

Units not equipped with protective plastic cover over electronics.

Firm Action

Siemens Medical Solutions USA, Inc issued a mandatory field update. The letter identified the product, the problem and the action to be taken by the customer. All systems that were not yet equipped with protective cover over the D972 board would be upgraded. For questions regarding this recall call (610) 448-3237.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, TX, VA, WA, WI, WY AND PUERTO RICO.

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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