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Terminated

Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX

FDA Recall Z-0154-06 · Posted 2005-11-16

Recalling FirmMedrad Inc
Recall StatusTerminated
Product CodeDXT
Date Initiated2005-10-10
Date Terminated2007-08-15
Product Quantity4362 units

Reason for Recall

the heat maintainer, an accessory, may overheat and deform the disposable syringe

Firm Action

The recalling firm issued an Urgent Medical Device Field Correction notice dated 10/12/05 via certified mail. The notice provided instructions to apply warning labels and disconnect the heat maintainer until a field upgrade kit is available. In case where the heat maintainer is a necessity for specific procedures, the customer is being instructed to observe certain precautions.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities nationwide. The products were also shipped to Canada, Isreal, Italy, Denmark, Netherlands, Norway, Great Britain, France, Poland, Germany, Spain, Finland, Belgium, Sweden, Russia, Austraila, Cuba, Mexico, Peru, Hong Kong, Korea, Mylasia, Thialand, Taiwan, Singapore, India, China, Turkey, Saudia Arabia, and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033881MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULEMedrad, Inc. · 2004-03-02K023183MEDRAD STELLANT CT INJECTOR SYSTEMMedrad, Inc. · 2003-01-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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