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CriticalFDAfda-Z-1985-2014FIRE OR BURN

Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems desig...

⚠ Critical FDA Safety Notice — Talk to Your Doctor

The FDA has flagged this as a serious safety concern (fire or burn). Do not stop, change, or discard a prescribed medication or medical device on your own. Contact your doctor or pharmacist immediately to ask whether this notice applies to your prescription and what to do next. Any specific guidance below comes directly from the FDA — Product Recall Tracker does not provide medical advice.

Units Affected
10
Recall Date
May 9, 2014
Issuing Agency
Hazard
Fire Or Burn

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1985-2014.

There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010 and April 2011 for the Siemens Mobilett XP Digital mobile X-ray System, which might occur at any time with higher probability while the system is being charged and connected to the main power supply.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1985-2014.

Recall terminated by FDA.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1985-2014.

Siemens Medical Solutions USA, Inc

FDA

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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

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Siemens Medical Solutions Usa, Inc Recall FAQ

Siemens Medical Solutions Usa, Inc is the subject of a medical devices safety report: Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems desig.... The notice was published on May 9, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 10 units are potentially affected.