***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0657-2014.
The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0657-2014.
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:
- 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-0657-2014.
The Anspach Effort, Inc.
About the U.S. Food and Drug Administration
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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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.
The Anspach Effort, Inc. Recall FAQ
The Anspach Effort, Inc. is the subject of a medical devices safety report: ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and.... The notice was published on April 25, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 12 units are potentially affected.