Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagn...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2152-2017.
During patient interventions with the urology table the radiation is activated with a footswitch connected to the table. This footswitch is actively involved in the safety circuit of the urological table. Only if footswitch + exposure + first primary barrier are closed the signal will be transmitted to the generator for activating X-ray. During intended use only with this footswitch X-ray should be activated.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2152-2017.
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:
- Do not stop, change, or discard your prescription on your own.
- 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).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- 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-2152-2017.
Hans Pausch Rontgengeratebau Gmbh
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Hans Pausch Rontgengeratebau Gmbh Recall FAQ
Hans Pausch Rontgengeratebau Gmbh is the subject of a diagnostic devices safety report: Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagn.... The notice was published on March 14, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 10 units are potentially affected.