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High RiskFDAfda-Z-1188-2013OTHER

GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-se...

Units Affected
166
Recall Date
July 25, 2011
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1188-2013.

Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspe

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1188-2013.

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:

  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-1188-2013.

GE Healthcare, LLC

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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Ge Healthcare, Llc Recall FAQ

Ge Healthcare, Llc is the subject of a medical devices safety report: GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-se.... The notice was published on July 25, 2011 by the U.S. Food and Drug Administration (FDA). Approximately 166 units are potentially affected.