MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgi...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1622-2013.
MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) and will make enhancements to the YUNO table (part number 1433.01F0). Identification of the Extension device issue: By fully actuating the lever of the extension device handle, the operator's skin can enter a gap between the handle lever and a recess in the handle bar. When the lever is released,
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1622-2013.
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-1622-2013.
Maquet Cardiovascular Us Sales, Llc
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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.
Maquet Cardiovascular Us Sales, Llc Recall FAQ
Maquet Cardiovascular Us Sales, Llc is the subject of a surgical devices safety report: MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgi.... The notice was published on April 26, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 13 units are potentially affected.