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Mobilett XP Hybrid/Digital/CR recallZ-0718-2011 · Siemens Medical Solutions USA, Inc · initiated Oct 4, 2010

Terminated All recalls posted in December 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

battery fuse

FDA root cause category: Other

What the company is doing

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].

Recall details

Recall number
Z-0718-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 4, 2010
Posted by the FDA
Dec 17, 2010
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
170 units
Product code
IZL
FDA submissions
K033238
Distribution
Nationwide distribution: AZ, CA, DC, MD, PA, SC and VA.

Product description

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

Code information (models, lots, serial numbers)

Model numbers 1818454, 1818447, and 1818959

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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