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Mobilett XP and Mobilett XP Hybrid, Mobile radiology device recallZ-0171-2011 · Siemens Medical Solutions USA, Inc · initiated Oct 4, 2010

Terminated All recalls posted in November 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Units not equipped with protective plastic cover over electronics.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0171-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 4, 2010
Posted by the FDA
Nov 1, 2010
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
177 units
Product code
IZL
FDA submissions
K033238
Distribution
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.

Product description

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

Code information (models, lots, serial numbers)

Model numbers 1818363 and 1818454

Other devices under the same FDA submission

2 devices cleared under K033238 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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